Clinical Trial Associate Job Description

A Clinical Trial Associate keeps a drug study's paperwork complete and inspection ready. In pharmaceutical sponsors and contract research organizations, the job usually sits inside clinical operations, supporting a Clinical Trial Manager while CRAs handle on-site monitoring, and it carries day-to-day accountability for the Trial Master File that FDA and EMA inspectors review under ICH GCP. The hard part is volume. One associate may track essential documents, ethics committee approvals, and site payments for several studies at once, and a single missing FDA 1572 form can stall a site activation.

As the Clinical Trial Associate, you keep essential study documentation accurate and audit ready so sponsor studies can activate sites on schedule and withstand regulatory inspection. You work within clinical operations alongside CRAs, CRO partners, and investigational sites, typically under the direction of a Clinical Trial Manager who relies on your tracking to steer study timelines.

Career Impact: Hands-on ownership of TMF and eTMF compliance gives you the GCP document expertise that sponsors and CROs expect before promoting associates to senior clinical operations titles.

Business Impact: Accurate essential-document tracking shortens site activation time, which lets investigators begin enrolling patients into the study sooner.

Growth Opportunity: The associate track commonly leads to Senior Clinical Trial Associate, then to Clinical Research Associate or Clinical Trial Manager as monitoring and budget duties expand.

• Own Trial Master File and eTMF maintenance for assigned studies, running periodic completeness reviews to keep files inspection ready.
• Coordinate collection of essential regulatory documents from sites and CRAs, requesting outstanding items before site activation.
• Support ethics committee and IRB submissions, amendments, and approval tracking in collaboration with the study team.
• Monitor study progress through trackers covering site activation, enrollment, and milestones, reporting status to study leadership.
• Liaise with CROs and vendors on study materials, supply shipments, and site requests to ensure timely delivery.
• Direct study meeting logistics, including agendas, minutes, and follow-up action items for internal and external teams.
• Review vendor invoices and site payments against contracts, maintaining accurate payment tracking for each study.
• Validate study documents such as protocols, informed consent forms, and case report forms for formatting and version control.

• Bachelor's degree in life sciences, healthcare, or a related scientific field or equivalent work experience.
• 1 or more years of clinical research experience, with exposure to sponsor or CRO study operations.
• Working knowledge of ICH GCP guidelines, FDA regulations, and local requirements governing clinical trial conduct.
• Understanding of essential documents, including protocols, informed consent forms, and case report forms, across study phases.
• Proficiency with office productivity and spreadsheet software for study tracking, reporting, and document preparation.
• Strong organizational skills with the ability to work independently while managing multiple studies and competing deadlines.
• Meticulous attention to detail when reviewing, filing, and reconciling regulated study documentation under inspection scrutiny.
• Clear written and verbal communication with sites, CROs, vendors, and internal study teams.

• Experience managing TMF or eTMF platforms in an outsourced sponsor environment, including audit and inspection preparation.
• Hands-on experience with clinical trial management, electronic data capture, and randomization systems for study tracking and reporting.
• Experience supporting ethics committee or IRB submissions, amendments, and continuing reviews from startup to closeout.
• Exposure to site payment, invoice, or budget tracking processes within sponsor or CRO clinical trials.

TMF completeness rate, showing how fully essential documents are filed.

Outstanding essential documents per site, tracking follow-up speed before activation.

Average days from document receipt to TMF filing, reflecting filing timeliness.

Audit and inspection findings on assigned TMFs, measuring filing accuracy.

Invoice and site payment processing time (days), reflecting payment tracking reliability.

Meeting minutes distributed within target timeframe, reflecting meeting support consistency.

Typical tools: Office productivity suite (commonly Microsoft Excel or Microsoft Word)

• Base Salary Range: $55,000 to $80,000 annually, higher for Senior CTA levels
• Bonus: Annual performance bonus of 5% to 10% of base salary
• Equity: Stock options or RSUs common at biotech sponsors, less common at CROs
• Health Benefits: Medical, dental, and vision coverage with 401(k) matching
• PTO: 15 to 25 days plus paid company holidays
• Common Perks: Tuition reimbursement, clinical research certification support, and hybrid work schedules

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Offers of employment are contingent on successfully completing a background check, which may include drug screening and verification of prior clinical research credentials. Candidates must be authorized to work in the United States. Reasonable accommodations are available on request at any stage of the hiring process. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by federal, state, or local law.

The Clinical Trial Associate owns setup, maintenance, and close out of the TMF, keeping study documentation inspection ready and aligned with ICH/GCP guidelines across assigned clinical trials. Reporting to clinical operations leadership and partnering with study leads and external vendors, the associate enables timely regulatory submissions and successful audits.

Key Responsibilities

• Assist in development of clinical trial documents, manuals, and trackers, and support informed consent development and version tracking.
• Prepare agendas and minutes for internal and external meetings, and maintain clinical operations tracking tools.
• Support HA and IRB/EC submissions, site start-up preparation, EC fee application and tracking, and site level payments and invoices.
• Support reporting for Senior Management updates and Clinicaltrials.gov and/or local registry posting and maintenance.
• Support distribution of site materials and equipment, document printing, shipment, and business and department office administration if required.
• Prepare the TMF Plan and/or map, and set up, maintain, and close out the TMF, coordinating document collection and uploading into SharePoint (SP)/eTMF.
• Ensure completeness, quality, and submission/inspection readiness of TMF content consistent with TMF specifications/plan, applicable SOPs, ICH/GCP guidelines, and regulatory requirements, and provide TMF/eTMF quality control (QC) if required.
• Act as the primary point of contact for TMF-related questions, issues, and internal and external audit queries, and support preparation of audit and inspection responses.
• Develop cross-functional relationships with internal and external TMF stakeholders, and monitor and report TMF progress to them.
• Oversee documentation flow within projected timelines and determine actions to prevent and remediate delays and errors with TMF compilation.
• Apply lessons learned to continuous improvement of documentation management practices, and educate, give feedback to, and guide study teams on good document management practices.
• Determine and review study specific TMF specifications to ensure quality and standardization per program, assess impact of changes before implementation, and collaborate with the study lead if modifications are necessary.
• Guide the Study Team in effective TMF management with external vendors, and mentor junior or less experienced associates where applicable.
• Communicate changes and progress, complete projects on time and budget, synthesize complex information, and collect and research data.

Required Qualifications

• Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline.
• Minimum of 2 years of clinical operations experience for Senior Associate, 1 year for Associate, and entry level for Junior Associate.
• Exceptions may be made case by case for candidates demonstrating an appropriate skill set and awareness of the Clinical Operations role.
• Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.
• Ability to work independently and handle multiple priorities in a fast-paced environment.
• Excellent interpersonal, organizational, and written and verbal communication skills across all levels within an organization.
• Respectful, trustworthy, ethical, and committed to organizational values.
• Able to prioritize and plan work, use time efficiently, complete administrative tasks correctly and on time, and follow management direction.
• Able to read and interpret written information.
• Strong teamwork, balancing team and individual responsibilities, giving and welcoming feedback, sharing expertise, and building positive team spirit.
• Able to adapt to changes, delays, and unexpected events.
• Accurate and thorough, with a focus on quality, applying feedback, and monitoring own work.
• Identifies and resolves problems in a timely manner and gathers and analyzes information skillfully.

Embedded within the Clinical Trial Management group, the Clinical Trial Associate delivers administrative and project tracking support from study start up through site closure, including preparation of clinical trial application documents for ethics committees. Working closely with the Director of Clinical Trial Management, research team members, and CROs, the associate maintains archived study files and helps clinical studies run efficiently.

Core Functions

• Provide general administrative support to the clinical research team members in the conduct of clinical studies.
• Assist the clinical research team members in their interaction with CROs/vendors.
• Assist in gathering, reviewing, and preparing clinical trial application documents for competent authority and ethics committee submission and approval, and gather essential documents for activating sites.
• Assist with generation and review of study specific documentation and plans as appropriate.
• Organize and maintain clinical study documentation (e.g. Trial Master Files, CRFs) including audit preparation, final reconciliation and archival, and assist in its quality control review.
• Coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.
• Assist with trial progress tracking by updating Clinical Trial Management systems and tools such as Excel spreadsheets.
• Address and route incoming correspondence, internal documentation, and CRFs as appropriate.
• Contact clinical sites and CROs for specific requests (e.g. enrollment updates, missing documentation, meeting arrangements, clinical supplies status).
• Assist in tracking and distribution of reports (e.g. metrics, safety reports, status communications) to stakeholders as directed, and coordinate document translation if required.
• Facilitate and attend project team meetings, assist with Investigator Meeting coordination and preparation, and generate meeting minutes.
• Assist in the production of PowerPoint slides and the review and format of documents such as the Investigator Brochure, study protocol, and publications.

Qualifications & Experience

• Bachelor’s degree in Life Sciences or related field.
• At least two years of experience working for a Clinical Research Department in the Pharmaceutical industry.
• Familiar with ICH GCP guidelines, local regulatory requirements, and clinical research principles and processes.
• Experience with clinical trial software such as EDC, eTMF, IRT, and CTMS.
• Proficient in Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams.
• Good organizational skills and ability to manage multiple tasks.
• Meticulous attention to detail.
• Strong interpersonal, written, and verbal communication skills.
• Demonstrates initiative, responsibility, autonomy, flexibility, and team spirit.
• High ethical standards and excellent judgment that guides decision-making.
• Committed team player.
• Familiar with ICH GCP, appropriate regulations, relevant company SOPs, and internal tracking systems.

Reporting to clinical development leadership under general supervision, the Clinical Trial Associate shapes study-related materials and tracks study projects through the CTMS across start-up, conduct, and close-out. Partnering with CRAs and clinical sites on CRF retrieval and query resolution, the associate helps the Clinical Development department meet its trial objectives.

Primary Duties

• Collaborate with the project team in the clinical study development process.
• Assist in the development and editing of study-related materials.
• Assist with planning, coordination, and presentation of information at Investigators’ meetings.
• Assist with site management at the direction of other clinical personnel.
• Assist the Clinical Team in supporting clinical sites and clinical team members during the conduct of clinical trials.
• Assist with management and tracking of study projects through the CTMS or other electronic means.
• Produce meeting minutes independently.
• Assist with management of investigational drug and study supplies by preparing and ensuring accuracy of shipments of study-related materials (e.g. drug orders, study binders, clinical documents, spreadsheets).
• Participate in co-monitoring or other site visits based on experience and training under guidance of the site’s assigned CRA or designee.
• Assist the CRA with the flow of data, including facilitating CRF retrieval and query resolution under guidance of the CRA or designee.
• Assist with collection, review, and filing of regulatory and other essential documents from clinical personnel (e.g. site trip reports) and sites (e.g. FDA 1572 forms).
• Assist with the data query resolution process.
• Assume a specialized administrative role (e.g. SOP Administrator, CTMS Administrator, TMF Administrator) as needed.

Skills & Qualifications

• BS/BA degree is preferred, or a minimum combination of experience and training depending on level.
• Minimum of 1-5 years of experience in a scientific medical field for Clinical Trial Associate and 5-12 years for Sr. Clinical Trials Associate.
• Solid working understanding of clinical protocols, CRFs, and all other associated study documents.
• Familiar with basic concepts of clinical research.
• Knowledge of the principles and practices of computer applications in database management.
• Advanced knowledge of Word, Excel, and PowerPoint.
• Strong interpersonal and collaboration skills.
• Clear and concise verbal and written communication skills.
• Ability to handle multiple tasks and deadlines.
• High degree of customer focus towards internal and external stakeholders.
• Ability to build and maintain positive relationships with management, peers, and subordinates.

Sitting at the intersection of clinical operations and vendor management, the Sr. Clinical Trial Associate leads eTMF maintenance and oversight of start-up activities for multiple clinical studies in an R&D setting. Operating across internal project teams, Clinical Operations Managers, and CROs, the Sr. Clinical Trial Associate supports delivery of quality studies that meet protocols, SOPs, and GCP principles.

Duties

• Assist the Clinical Operations Manager(s)/Project Team to prepare and maintain eTMF, ensuring tracking of essential study documents and periodic review to assure accuracy and completeness.
• Inform the Clinical Operations Manager/Project Team on any outstanding documents.
• Assist in tracking and oversight of all start-up activities (site and country study submissions, clinical trackers, essential documents status) and oversight of third party vendors.
• Participate in project management meetings and provide a regular overview of TMF status, clinical study administration, resources, quality, and workload.
• Support the Clinical Operations Manager(s) in coordinating project meetings, including scheduling and drafting, distribution, and filing of agendas and minutes.
• Communicate effectively with clinical study administration vendors (Functional Service providers etc.).
• Assist in coordination of Investigator and Vendor payments, and tracking of payments and accruals, if applicable.
• Assist in data listing review and clinical study report listing review.

Requirements

• Bachelor's degree, or equivalent, in a biomedical, life science, or related field is preferred.
• Associates degree with 5 years of clinical operations experience may be considered.
• 3-5 years of experience needed.
• Experience managing eTMF platforms in an outsourced environment is required, with a minimum of 2 years strongly preferred.
• Understanding and working knowledge of regulations and standards applied in clinical areas, medical devices, and/or pharmaceutical products is required.
• Familiarity with GCPs, ICH guidelines, and FDA regulations is preferred, and familiarity with EMA/CHMP and other international regulatory requirements is a plus.
• Proficiency with Microsoft Word, PowerPoint, Outlook, and Adobe Acrobat is required.
• Strong skills with Microsoft Excel and SharePoint are required.
• Good problem-solving skills, strong sense of urgency, keen attention to detail, and ability to work independently and manage multiple priorities under time and resource pressures.

A key member of the clinical programs team, the Clinical Trial Associate builds study reference manuals, trackers, and newsletters while managing internal TMFs for multiple trials. Collaborating across study teams, vendors, and senior management, the associate organizes data and metrics that inform study decisions and successful execution.

Functions

• Manage internal Trial Master Files (TMFs) and/or review external TMFs to ensure suitable quality and completeness of files.
• Schedule and coordinate clinical project meetings, and prepare agendas, presentation materials, and minutes.
• Compile study materials, including study reference manuals, pharmacy manuals, and laboratory binders, and maintain versioning of all study reference materials.
• Contribute to review of study documents such as informed consent forms and case report forms, and facilitate document reviews per company SOPs.
• Generate and distribute study-specific newsletters.
• Prepare and maintain study trackers (e.g. investigators, enrollment), and organize data and metrics for analysis by the study team and senior management.
• Manage ancillary clinical study supplies and participate in vendor oversight activities.
• Support clinical trial registry postings (e.g. ClinicalTrials.gov).
• Manage and maintain team SharePoint sites, as needed.
• Follow SOPs, GCP, and all applicable regulatory requirements in all tasks.
• Perform other tasks as needed for successful study execution and as requested by Management.
• Complete all company and job-related training as assigned within the required timelines.

Experience & Qualifications

• Bachelor's degree, with a degree in Life Sciences preferred.
• At least three years of relevant clinical research experience (CRO or sponsor).
• Understanding of ICH-GCP guidelines and other clinical trial regulatory requirements.
• Strong skills with Microsoft Office (Word, Excel, PowerPoint, and Publisher).
• Excellent communication, organizational, and problem-solving skills.
• Very strong attention to detail.
• Ability to effectively multi-task in a dynamic start-up environment.
• Able to perform all essential functions of the position, with or without reasonable accommodation.

Complete and well-organized study files depend on the Clinical Trial Associate, who delivers (e)TMF filing, document collection, and Investigational Site Folder preparation as primary file holder for assigned studies. Serving under the Clinical Trial Manager and alongside CRAs and clinical sites, the associate supports study planning through completion.

Accountabilities

• File all clinical trial documentation in (e)TMF and paper TMF under the direction of the CTM, as assigned.
• Schedule, prepare, and take minutes for study team meetings.
• Work directly with the study/CRA team and sites to collect documents and maintain the files.
• Prepare Investigational Site Folders (ISF) for study start-up.
• Work with study vendors and schedule meetings as required.
• Prepare and handle study supply materials and ship them to sites.
• Run study procedure reports as required (i.e. EDC, study supply, IRT).
• Maintain the study’s (e)TMF, request outstanding documents as needed, and periodically review the TMF for completeness.
• Complete the (e)TMF study file checklist for each study prior to close-out to assist the study team in updating the files.
• Prepare the files for internal and external audits, as required.
• Ensure training and applicable Sponsor information and/or materials are completed for the position, and assist in maintaining study team training files as needed.
• Assist in site payment activities, as required.
• Complete any other administrative tasks and tasks assigned by the direct manager.

Technical Qualifications

• A College degree, preferably in sciences/medical sciences.
• At least 3 years of pharmaceutical industry or clinical research site-based experience.
• Working knowledge of clinical drug development and clinical operations processes, with experience applying GCP, ICH, and FDA requirements.
• Knowledge of Regulatory and ICH GCP guidelines.
• Proficiency in Microsoft Office (i.e. Word, Excel, PPT, Email) and Audio/Video conferencing tools (i.e. WebEx, Skype).
• System experience preferably in CTMS, eDC, and (e)TMF applications.
• Strong communication, organizational, and motivational skills.
• Ability to perform issue escalation.
• Flexibility and ability to work with deadlines.
• Ability to operate independently as well as be a Team Player.
• A solution-oriented and problem-solving attitude.

As the Clinical Trial Associate, this role shapes customer onboarding and implementation of a cloud-based SaaS platform used by clinical research professionals, including environment setup and usage reporting. The Clinical Trials team relies on this work to ensure account success, while feedback to product development helps speed the progression of clinical trials.

Activities

• Learn and develop expertise in the company’s cloud-based SaaS platform.
• Set up the platform environment in preparation of introductory and kick-off meetings.
• Track and maintain a log of customer engagements and training.
• Monitor and report on customer usage of the platform.
• Streamline the customer onboarding experience.
• Ensure seamless implementation of the platform.
• Update regular metrics on trial.
• Deliver regular updates to customers.
• Support the Clinical Trials team to ensure the success of the account.
• Provide feedback to help guide product development.

Position Requirements

• BA or BS degree in business, science or related field.
• 1+ years of relevant experience in a client-facing role, preferably within a SaaS technology or healthtech company.
• Experience working directly with customers or clients and championing their long-term success.
• Prior experience in Life Sciences clinical research/clinical trials preferred.
• Implementation and/or training skills, preferably within a SaaS or PaaS tool.
• Extensive experience working with Excel and PowerPoint.
• Excellent collaborative and interpersonal skills.
• Effective oral and written communication and presentation skills.
• Ability to thrive in a fast paced, start-up environment.
• Excellent organizational skills and impeccable attention to detail.
• Solution-oriented thinking, a zest for learning, and a willingness to help whenever needed.

Clinical Trial Associate delivers operational support for global clinical trials from start-up to close-out, managing an ICH GCP compliant Trial Master File, site contracts, and invoice tracking in a pharmaceutical setting. The work directly supports clinical study team members, CROs, and subcontractors, enabling timely study start up and sound financial records for each study.

Operational Focus

• Support operational execution of global clinical trials, from start-up activities until study close-out.
• Ensure operational support of clinical study teams, including taking and distributing meeting minutes and following up action items.
• Interact with the project team and external service providers including CROs and subcontractors to assist with study start up, including site feasibility management, site set up, and tracking of site contracts, study insurances, EC or regulatory approvals, and other trial documentation.
• Set up, manage, and maintain an ICH GCP compliant Trial Master File and assist in review and audit of vendor Trial Master Files to ensure compliance.
• Develop and maintain appropriate tracking tools for trial related metrics.
• Draft and/or provide input into department SOPs and procedures.
• Support CST members in the coordination of contracts with sites/vendors/KOL.
• Assist in organization of Investigator’s meetings.
• Ensure trial invoices are processed in a timely manner, and maintain financial records and an invoice tracking list for each study.

Knowledge Skills & Abilities

• Scientific educational background (Bachelor’s degree or equivalent degree).
• At least 3 years of experience in clinical trial support in the Pharmaceutical Industry or CRO.
• Good understanding of the drug development process.
• Familiar with clinical trial documentation, regulatory needs, and ICH GCP requirements.
• Excellent user of Office Programs (Word, Excel, PowerPoint).
• Fluency in English.
• Good oral skills in French.

The Clinical Trial Associate oversees quality control of TMF and CTMS records while tracking feasibility, CDA timelines, and CRO trackers for clinical studies, including medical device trials. Reporting to the clinical operations team, the associate supports corrective and preventive actions that keep trials compliant with ICH/GCP guidelines.

Key Deliverables

• Set up trial meetings, take meeting minutes, and manage rosters.
• Support document creation, review, and feedback coordination.
• Perform quality control of TMF and CTMS.
• Collate and track information and timelines (feasibility, CDA).
• Support TMF review and tracking of CRO.
• Track study tools, including internal trackers and CRO trackers.
• Manage study-related supplies and study-related material requests.
• Manage Compliance reports.
• Support coordination of document translation management.
• Participate in projects for the overall clinical operations team.

Professional Experience

• Bachelor's degree or equivalent, preferably in Nursing, Medicine or other Life Sciences, or RN degree from an accredited school or equivalent work experience.
• Minimum of 1-year clinical trial experience in various activities from initiation to closure, with on-site monitoring preferred (CRO or industry experience acceptable).
• Experience in TMF set-up, maintenance, and periodic reviews.
• Experience identifying potential deficiencies in trial progress and assisting in/suggesting corrective and preventive actions (CAPA).
• Detailed knowledge of the Clinical Trial Process, including ICH/GCP guidelines.
• Familiarity with clinical research, with Oncology a plus.
• Familiarity with Medical Device regulations, clinical trials, and ISO.

Embedded within a global study team under departmental supervision, the Clinical Trial Associate advances Trial Master File processing, document tracking, and amendment tasks such as IRB/EC submissions across multiple studies. Working closely with Project Managers, CRAs, sites, and vendors, the associate keeps document collection on schedule and supports regulatory inspections and audits.

Areas of Ownership

• Participate in internal and external meetings, provide updates, and take minutes or assist in action/decision log maintenance.
• Support regulatory inspections and/or audits and interface with vendors as required.
• Procure, maintain, and ship study documents, supplies, and materials in compliance with company SOPs and study-specific processes.
• Maintain study servers and portals, and track documents and study status in applicable tracking systems.
• Report document collection and tracking issues to the functional lead and/or study team on a regular basis.
• Identify, manage, escalate where appropriate, and resolve site issues, and assist with ad hoc issue resolution as directed.
• Communicate functional area study status and provide associated reports to the study team as appropriate.
• Submit documents and/or files within TMF, conduct document review, and support document query resolution.
• Support site level document collection via CRA and/or directly from sites, and assist ongoing completeness review of assigned TMF content.
• Conduct designated final site level TMF review and provision partial final document collection expectations by CRA at Close Out Visit.
• Support the study team with TMF functionality and use per the study-specific TMF Plan, company SOPs, and study-specific processes.
• Review and maintain study Outlook folders, provide correspondence to sites, sponsors, and study team members, and conduct fee tracking and/or data entry.
• Assist with amendment tasks including site notification, supply shipment, budget update, IRB/EC submission, and ICF review, and support safety letter distribution to sites and IRB.

Education & Experience

• College/University graduate preferred, with a healthcare or life science degree a plus.
• Equivalent combination of education and relevant work experience considered.
• Prior relevant work experience preferred.
• Strong computer skills, including Microsoft Office.
• Strong interpersonal skills.
• Team-oriented and a strong team player.
• Exceptional attention to detail and highly organized.
• Able to work in a dynamic, changing environment.
• Honesty, trust, fairness, cooperation, self-control, and flexibility.
• Interest in learning medical terminology.
• Strong English language written and verbal communication skills.

Reporting to the Program/Project Managers, the Clinical Trial Associate oversees regulatory documents such as FDA 1572 forms and QC of CRO deliverables from site initiation to close out. Partnering with investigators, Medical Monitors, and CROs, the associate tracks site activation and enrollment so studies meet departmental and project goals.

Role Responsibilities

• Create and/or review study plans, specification documents, materials, and tools.
• Oversee documents (e.g. FDA 1572, CVs, FDF) required for company Regulatory from site initiation to site close out, and provide QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs, and timelines.
• Be familiar with CRA roles including site visits, and assist in organizing, scheduling, and attending site visits if required.
• Develop and maintain good working relationships with investigators and site staff, and act as liaison between sites and Medical Monitors to ensure follow up/closure of action items.
• Ensure trial sites carry out recruitment and screening per the study protocol, ICH/GCP regulations, and study-specific guidelines.
• Identify and monitor progress and obstacles of assigned studies by implementing follow up strategies on action items from site visits or site communication.
• Assist in set-up, organization, and maintenance of project SharePoint (folders, documents), and support submission of Sponsor study team documents required for TMF.
• Support planning and logistics for investigator, study team, CRO, and vendor meetings, generate, finalize, and distribute agendas and minutes, and review CRO meeting minutes.
• Assist in the production of slides and attend and contribute to internal meetings and CRO/vendor project meetings.
• Track and report study progress including site activation, recruitment activities, patient enrollment, and CRO monitoring visits where assigned.
• Review key study quality metrics (e.g. eligibility, primary endpoint data) and determine appropriate action with the study team.

Background & Experience

• Bachelor’s degree in science.
• At least 5 years of experience in randomized clinical trials in central nervous system indications.
• Prior experience in the role of CTA for randomized clinical trials.
• Familiar with ICH GCP, appropriate regulations, relevant company SOPs, and internal tracking systems.
• Versatile with MS Office applications (Word, Excel, PowerPoint) and SharePoint cloud services.
• Highly organized with excellent communication skills.
• Works well with a multidisciplinary internal clinical team and in interactions with CROs/vendors.
• Ability to communicate clearly verbally and in writing to sites, vendors, CROs, and the internal study team.

Sitting at the intersection of study administration and regulatory submissions, the Clinical Trial Associate develops electronic master file documentation, payment activities, and drug importation support for study sites. Operating across the study team, Local GRS, Ethics Committees, and vendors, the associate helps secure approvals and keeps sites supplied throughout the study life cycle.

Job Functions

• Set up vendors during the study start-up period (operational details from sites).
• Enter necessary data and tracking in systems (i.e. ECLIPSE, eTMF, SAP).
• Maintain documentation within the electronic master file and other systems (i.e. Mytrials/Shared Investigator Portal), including completeness checks.
• Arrange drug and non-drug (Lab kits, ECG) importation to support study sites.
• Complete all payment activities including preparing invoices, Payment Due Reports, and creating fund/PO.
• Collect and distribute documents from and to sites during the study life cycle.
• Coordinate study related materials and documents (i.e. protocol, ICF, patient material, IB) for translation, printing, and binding.
• Provide administrative support to the study team (study related mailing, bill processing, printing, translation).
• Obtain insurance certificates.
• Prepare the On Site Investigator File and other study related files.
• Support equipment calibration and tracking, and handle the archiving process at study closure.
• Support Local GRS in preparing and/or performing Health Authority submissions, including substantial amendments, with follow up until approval.
• Prepare and perform Ethics Committee submissions (protocol, amendments/IB) with follow up until approval.
• Support Health Authority inspection and pre-inspection activities, audit preparation, and CAPA preparation for local issues.

Minimum Qualifications

• Degree within Life Sciences, Administrative, Financial or Accounting related field.
• Previous experience in Clinical Research or related work experience.
• Experience managing multiple priorities and accomplishing tasks within a timeframe, setting milestones to meet deadlines and achieve goals.
• Basic understanding of GCP, ICH Guidelines, and local regulations as they apply.
• Basic knowledge of the drug development process as it relates to clinical trial execution, with a focus on document flow.
• General knowledge of software systems and web-based applications, with good computer aptitude and willingness to learn new systems and applications.
• Experience with industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent preferred.
• Experience with additional complex clinical trial software (i.e. electronic data capture, patient diaries, interactive voice response) preferred.
• Able to use Microsoft Suite, CTMS, eTMF, and Document Exchange Portals independently and without assistance.
• Demonstrates ability to function independently.
• Good verbal and written communication skills in both English and the local language.

A key member of Clinical Operations Project Management, the Clinical Trial Associate produces project plans, meeting minutes, and audit-ready Trial Master Files for assigned studies. Collaborating across the Project Manager, Sponsors, sites, and vendors, the associate keeps project communication accurate and on timeline.

What You'll Do

• Assist the assigned PM with drafting project plans and creating project documents prior to Sponsor review.
• Act as a central contact for the clinical team for designated project communications, meeting coordination, meeting minutes, correspondence, and associated documentation.
• Assist the PM with project coordination, including weekly Sponsor and Investigator calls, maintaining project trackers, and communicating on behalf of the PM to the Sponsor, sites, and vendors.
• Schedule all clinical project meetings in consultation with the PM, and prepare and distribute agendas and minutes for team meetings with PM review for accuracy.
• Update and maintain clinical systems accurately within the appropriate project timeline.
• Prepare and manage assigned Trial Master Files per standard guidelines in an audit-ready state.
• Prepare, handle, distribute, file, and archive clinical documentation and reports.
• Maintain accurate team contact lists for every assigned project and upload them to the TMF at least yearly.
• Gather, track, and maintain project and site essential regulatory documents.
• Prepare and compile study related materials including investigator meeting binders, training manuals, Site regulatory binders, and Site study binders.
• Provide cross functional clerical and administrative support to project teams, including front office support, meeting support, and other clinical trial execution tasks.

Required Qualifications

• Associate degree in a life science or health related field preferred.
• Minimum of four years of experience in an administrative role.
• At least two years of experience supporting clinical research, with preference to oncology research.
• Knowledge of GCP, ICH guidelines, and clinical trial regulations.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
• Strong written and verbal communication skills.
• Time management and organizational skills.
• Ability to work collaboratively in a team environment.

Inspection-ready clinical documentation depends on the Senior Clinical Trial Associate, who oversees TMF and eTMF maintenance, document distribution, and vendor invoice tracking for in-house or outsourced trials. Based within the Clinical Operations department and working with the Clinical Trial Manager, the Senior Clinical Trial Associate supports well-planned and compliant trial execution.

Day-to-Day Responsibilities

• Collect, file, and track clinical trial regulatory documents for the Trial Master Files.
• Coordinate and track distribution and retrieval of clinical documents, including protocols, protocol amendments, IBs, ICFs, and monitoring visit reports.
• Maintain all documentation in a state of audit readiness, and maintain the TMF and eTMF according to ICH-GCP and company SOPs.
• Assist in preparation of study related documents, i.e. ICF, clinical trial tools and templates.
• Support drug supply planning and defining supply logistics.
• Coordinate and track clinical trial equipment and supplies.
• Review and track vendor invoices against contracts and coordinate approval.
• Assist with the site budget process.
• Support the trial team to produce and distribute study newsletters.
• Create agendas and record team meeting minutes under the direction of the Clinical Trial Manager.
• Assist the Clinical Trial Manager with timeline maintenance.
• Provide administrative assistance to the clinical team as needed, including booking meetings and conference rooms and assisting with expenses.

Qualifications & Experience

• Bachelor’s degree in life sciences or healthcare related field.
• 2-4 years of experience working in the pharmaceutical/biotech industry.
• Solid understanding of the responsibilities and needs of other functions in a clinical trial.
• Strong computer skills including MS Excel, Word, PowerPoint, and Outlook.
• Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment.
• Ability to maintain confidentiality of proprietary information.
• A team player who takes initiative.
• Excellent interpersonal and organizational skills, and effective communication across all levels within an organization.
• Proficient written and verbal communication skills.

As the Clinical Trial Associate, this role refines packaging, labeling, storage, and distribution processes for clinical trial supplies, including in-process checks and receiving tests. The clinical trial packaging team relies on this work to help Clinical Trial Coordinators, Logistics, and Quality execute projects from start-up through close-out.

Scope of Work

• Assist the Clinical Trial Coordinators and Head of Production in writing technical procedures and Standard Operating Procedures.
• Develop and prepare processes relating to clinical trial packaging, labeling, storing, and distribution.
• Accurately document all packaging material specifications, detailed packaging directions, descriptions, and requirements from the CTC.
• Complete receiving procedures and product specification tests.
• Conduct in-process checks to ensure procedures are accurately performed by all staff in the Clinical Trial Packaging area during packaging and labeling.
• Direct and train Packaging Assistants in the preparation/packaging of study medications and all necessary study specific duties.
• Ensure compliance with environmental and health/safety standards.
• Accurately monitor clinical trial supplies/inventory, as required.
• Process requests and respond to inquiries delegated from CTCs in a timely manner.

Skills & Qualifications

• Completion of either a BSc or equivalent education.
• Completion of Accredited GMP courses is an asset.
• Experience relating to project management.
• Experience relating to quality assurance is an asset.
• Relevant clinical trials experience preferred.
• Excellent knowledge of MS Office.
• Excellent interpersonal skills and ability to collaborate with multiple stakeholders.
• Excellent written and verbal communication.
• Effective group facilitation and problem-solving skills.
• Ability to take direction and absorb information quickly.
• Ability to multi-task and take initiative.

Clinical Trial Associate develops study-specific documents such as informed consent forms and CRFs, prepares IRB submissions, and maintains TMF and regulatory binders from start-up through closure. Success in the position means supporting investigators, site staff, and cross-functional teams so studies meet Good Clinical Practice and SOP requirements.

Work Activities

• Coordinate operational aspects for the execution of study activities from start-up through closure while ensuring Good Clinical Practice and relevant SOPs are met.
• Prepare IRB submissions and maintain up-to-date IRB compliance including approvals, continuing reviews, amendments, and post-approval reports.
• Provide input into and/or develop study-specific documents such as informed consent forms, protocol, subject-facing material, Case Report Forms (CRFs), and study plans.
• Perform site qualification, initiation, monitoring, and closeout visits with manager oversight.
• Create and maintain Trial Master Files (TMF) and regulatory binders while adhering to data retention policies.
• Assist with data entry, database management, and use of electronic data capture (EDC) systems.
• Communicate with and support Investigators and site staff throughout the study, and track site performance metrics such as enrollment.
• Manage internal and external tools such as study trackers, dashboards, insurance, training, and document control.
• Support SOP development and implementation activities for the clinical research operations team.
• Work both independently and collaboratively with cross-functional teams.

Requirements

• Bachelor’s degree.
• CITI and HSP training.
• Minimum of two years of experience in clinical research, preferably at a sponsor company.
• Experience with Institutional Review Board (IRB)/Independent Ethics Committee (IEC) activities from study startup to closeout.
• Ability to use critical thinking to analyze problems which may require multiple factors and approaches.
• Great verbal and written communication skills.
• Excellent organizational skills along with strong attention to detail.
• Works independently and collaboratively.

The Clinical Trial Associate II creates site identification surveys and feasibility reports for oncology protocols across a research network, drawing on CTMS and other data sources. Reporting to the clinical trial manager, the associate supports operational and business objectives through accurate study data and administrative support.

Performance Expectations

• Create site identification surveys for all phase protocols within the oncology research network by reviewing the protocol document, sponsor feasibility questionnaires, and details from the clinical trial manager and manager of clinical programs.
• Work closely with the clinical trial manager to analyze data from CTMS, a feasibility tool, and other sources to understand site study needs and patient population.
• Retrieve, consolidate, and analyze data and present reports to the team to support operational and business objectives.
• Enter new study information into various databases.
• Generate reports from various databases to support program management needs.
• Provide administrative support to the clinical operations team, including scheduling meetings and calls, following up on outstanding sponsor documents, creating site provision lists, taking minutes, and supporting overall business initiatives.
• Support the operations team with managing selected clinical research studies with a low number of active patients on treatment and those with only patients in follow-up.

Experience & Qualifications

• Bachelor’s degree in clinical or scientific discipline.
• At least one year of clinical research experience or two years of business environment experience required.
• Prior oncology research experience preferred.
• Proficiency with computer systems and Microsoft Office required.
• Attention to detail, solid execution, and meeting aggressive timelines.
• Strong interpersonal skills and team player.

Embedded within a cross functional project team spanning research, CMC, QA, and Clin-Ops, the Sr. Clinical Trial Associate coordinates site, country, and vendor management, including support for CRO site selection and TMF QC. Working closely with the Clinical Trial Manager/Director, the Sr. Clinical Trial Associate helps move clinical development programs through every stage of execution.

Core Responsibilities

• Act as contact person/link between study site personnel, CROs, and other vendors.
• Support in designing study procedures and manuals.
• Support the CRO in country and site selection, qualification, and start-up procedures.
• Provide country and site oversight during trial execution, including accompanied site visits.
• Set up and support logistic organization, i.e. IMP or Lab.
• Review protocols, IBs, CRFs, SAPs, tables/listings, statistical reports, study reports, and publications as needed.
• Participate in clinical development teams.
• Assist the Clinical Trial Manager/Director with timeline maintenance and overall study needs.
• Present study plans, updates, and outcomes internally and externally (e.g. during investigator meetings).
• Assist/manage the budget of studies or ancillary vendors.
• Support management, tracking, and QC of the Trial Master File (TMF), including set up and maintenance in line with ICH/GCP.

Technical Qualifications

• Minimum Bachelor’s degree, with a medical or related degree preferred.
• 2-5 years of relevant industry experience within clinical development.
• Solid understanding of the responsibilities and needs of other functions in a clinical trial.
• Extensive knowledge of current ICH-GCP regulations, with knowledge of ATMP preferred.
• Recent and active knowledge of MS Office applications.
• Strong organizational skills and effective communication across all levels within an organization.
• Accurate with an eye for detail.
• Enthusiastic, proactive, flexible, and adaptive attitude.
• Strong networking/relationship management.
• Learning oriented and able to continuously self-improve.
• Able to think creatively, provide innovative solutions to (non-)standard problems, solve day-to-day problems, and take responsibility for decisions.
• Able to work with/around sensitive and confidential information.
• Fluent in English, verbal and written.

Reporting to the Director of Clinical Compliance, the Clinical Trial Associate executes study tracking, CTM forecasting, and inspection readiness activities for detail-heavy clinical study assignments. Partnering with QA and CTM vendors, the associate promotes consistent Clinical Operations processes and well-maintained study documentation.

Key Responsibilities

• Provide general logistical support for clinical trials and study-specific work, including generation of study materials, tracking of study milestones and metrics, and QC of study documents such as clinical protocols.
• Establish and maintain tracking tools for clinical studies.
• Support the Clinical Operations Department by coordinating department meetings, creating and updating slides and meeting materials, capturing meeting minutes, and tracking action items as required.
• Assist with Clinical Trial Material (CTM) forecasting, engage with CTM vendors, and work with the Director, Clinical Compliance and QA to manage CTM timelines and deliverables.
• Support development, implementation, and maintenance of SOPs, work instructions (WIs), forms, and templates to improve quality and promote consistency for company-sponsored clinical studies.
• Assist with inspection readiness activities, including set-up and maintenance of inspection preparation files and coordination and support during and following an inspection.
• Organize and prepare study files, ensuring study documentation is maintained at the company and vendors according to applicable regulations, industry accepted standards, and SOPs.

Position Requirements

• Bachelor’s degree.
• 2 years’ experience in a CRO, pharmaceutical, or biotechnology company.
• Experience managing a study trial master file and knowledge of best practices in TMF management.
• Quality (GCP) and/or Clinical Trial Material management experience is a plus.
• Tech savvy with high proficiency in Microsoft Excel, as well as Project, Word, and PowerPoint.
• Logical thinker who is highly adaptable, proactive, deadline- and detail-oriented.
• Willing to embrace new challenges and take on increasing levels of responsibility.
• Thrives in a fast-paced environment, working independently under general direction and as part of a team, and able to shift priorities as needed.

Sitting at the intersection of site contracting and clinical trial start-up, the Clinical Trial Associate executes budgets and contracts with site and affiliate personnel while meeting country specific regulatory and data privacy requirements. Operating across sites, internal teams, and procurement, legal, and financial functions, the associate helps reach enrolment ready timelines and improves contracting efficiency.

Core Functions

• Communicate, negotiate, and execute budgets and contracts with the appropriate site, team, or affiliate personnel.
• Communicate directly with sites to enable start-up and maintain active collaboration with sites and the internal team to meet enrolment ready timelines.
• Identify, communicate, and resolve issues.
• Ensure country specific regulatory and data privacy requirements are met.
• Increase contracting efficiency and effectiveness by ensuring learning is shared and leveraged.
• Populate internal systems to ensure accuracy of trial/site performance.
• Understand and comply with procurement, legal, and financial requirements and procedures.
• Populate Trial Master Files and libraries for future reference.
• Provide feedback and shared learning for continuous improvement.
• Leverage trial prioritization.
• Anticipate and monitor dynamically changing priorities.

Knowledge Skills & Abilities

• Bachelor’s degree preferred.
• At least two years of experience in contracts and budgeting, ideally in a clinical trial or other compliance-driven environment.
• Applied knowledge of project management processes and skills.
• Ability to learn and comply with financial and legal guidelines and policies.
• Strong attention to detail.
• Strong critical thinking and analytical skills.
• Effective communication, negotiation, and problem solving skills.
• Self-management and organizational skills.
• Language capability in one of English, German, French, Spanish, Italian, Polish, Swedish, Danish, Finnish, Czech, Hungarian, Romanian, Dutch, Portuguese, Flemish, or Swiss German.