Clinical Trial Assistant Job Description

A Clinical Trial Assistant keeps a sponsor's trial paperwork complete and ready for inspection. In pharmaceutical and biotech companies, the position sits inside clinical operations under a Clinical Trial Manager, holding custody of the Trial Master File while site monitoring stays with field-based CRAs. The hard part is volume. Every study generates essential documents, IRB and ethics committee packets, and site payment records that must satisfy ICH-GCP at any audit, often across several concurrent protocols and investigator sites in multiple countries.

As the Clinical Trial Assistant, you safeguard the documentary record of sponsored studies so that submissions reach regulators and ethics committees on time and the Trial Master File withstands inspection without findings. Working within a pharmaceutical or biotech clinical operations group, you support Clinical Trial Managers and CRAs on one or more protocols from start-up to closeout.

Career Impact: TMF stewardship and IND document review give you regulatory fluency valued when Senior CTA roles open.

Business Impact: Accurate IMP accountability and on-time site payments keep investigator sites enrolling patients instead of chasing contracts or paperwork.

Growth Opportunity: Owning ICF and essential document packet reviews prepares you for Clinical Trial Manager scope on bioequivalence or small molecule programs.

Company Value: Sponsor teams of roughly 10 clinical R&D professionals mean direct exposure to a vice president of clinical research.

• Maintain the Trial Master File, conducting periodic completeness reviews and correcting filing locations to ensure inspection readiness.
• Coordinate essential document packets and IRB/EC submission materials with investigator sites to support timely study start-up.
• Track study milestones, site activation, and enrollment metrics, producing written status updates for Clinical Trial Managers.
• Process investigator site and vendor payments, reconciling invoices and purchase orders against study budgets and contracts.
• Organize study team and investigator meetings, preparing agendas, distributing minutes, and following up on action items.
• Manage ordering, shipment, and tracking of trial supplies and investigational product accountability for study sites.
• Review study budgets and clinical trial agreements for consistency with the protocol before execution.
• Support SOP updates and process improvement initiatives within clinical operations to maintain GCP compliance.

• Bachelor's degree in life sciences or a health-related field, or equivalent work experience.
• 1 or more years of clinical research administration experience, with exposure to pharmaceutical or biotech sponsor studies.
• Working knowledge of ICH-GCP guidelines and local clinical trial regulations governing essential documents and regulatory submissions.
• Understanding of Trial Master File structure, filing conventions, and inspection readiness expectations for sponsor audits.
• Proficiency with office productivity software, including building spreadsheets for study tracking, budgets, and reporting.
• Strong attention to detail, keeping accurate records across concurrent studies, sites, and document versions.
• Ability to prioritize multiple tasks independently and re-prioritize when study timelines or priorities shift.
• Clear written and verbal communication in English with sites, vendors, and internal study teams.

• Experience with clinical trial management, electronic data capture, or electronic TMF systems in a sponsor setting.
• Familiarity with IND submissions, IRB/IEC approvals, investigational product accountability, and safety report distribution processes.
• Background supporting small molecule drug development or bioavailability and bioequivalence trials at a pharmaceutical sponsor.
• Fluency in a second European language such as French or Dutch for multi-country studies.

• TMF completeness rate, showing documents filed correctly at periodic review.
• Essential document packet turnaround in days, reflecting speed of site start-up support.
• Site and vendor payment cycle time in days, measuring invoice processing accuracy and speed.
• IMP accountability reconciliation rate, confirming supplies tracked from shipment to return.
• Meeting minutes distribution time in hours, reflecting follow-through on study team actions.
• Typical tools: Office productivity suites (commonly Microsoft Excel or Word).

• Base Salary Range: $45,000 to $65,000 per year for mid-level sponsor roles
• Bonus: Annual performance bonus of 5% to 10% of base salary
• Equity: RSUs or stock options common at biotech companies, less at large pharma
• Health Benefits: Medical, dental, and vision coverage with employer-paid premiums and HSA or FSA options
• PTO: 15 to 20 days plus company holidays and a year-end shutdown
• Common Perks: Tuition reimbursement, hybrid schedules, and funded GCP or ACRP certification training

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 a satisfactory background check and, where required by the sponsor or study, a drug screening. All qualified applicants will receive consideration without regard to any characteristic protected by federal, state, or local law. Candidates must be authorized to work in the United States. Reasonable accommodations for applicants with disabilities are available throughout the hiring process upon request.

The Clinical Trial Assistant delivers administrative support for an international multi-center clinical study, managing Trial Master File documentation, regulatory submissions, budgets, and meeting coordination. Reporting to the Trial Central Office and working with the Data Management Team, the Clinical Trial Assistant keeps study records compliant with ICH-GCP and audit ready.

Key Responsibilities

• Provide general administrative support to the Trial Central Office and Data Management.
• Assist Regulatory work (preparation of applications for regulatory and ethical approval).
• Assist the Trial Central Office in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports included in the Trial Master File according to laws, regulations, ICH-GCP and internal standard operating procedures (SOPs).
• Check and forward incoming correspondence.
• Assist in the preparation of budgets and management of invoices and payments.
• Perform administrative tasks to support Consortium team members.
• Assist the Trial Central Office with Meeting coordination and preparation of related activities.
• Assist the Study Data Management Team with data management activities/tasks.
• Assist in the set-up, updates of SOPs.
• Produce administrative SOPs.
• Update and maintain the study web portal.
• Assist in preparation of internal/external audits.
• Undergo comprehensive in-house protocol training.

Required Qualifications

• University degree in life sciences or country's educational equivalent.
• Administrative support experience or equivalent combination of education, training and experience.
• Relevant work experience from clinical research or examination from "Klinisk läkemedelsutveckling 30 hp, CDD" at a university or equivalent.
• Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Ability to establish and maintain effective working relationships with co-workers and collaborators in the trial.
• Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• Ability to thrive in both individual and team settings.
• Driven, well-organised and detail oriented with good coordination and communication skills.
• Willingness to perform a variety of tasks within the clinical trial workflow.
• Proficiency in written and spoken English.
• Fluency in Swedish language preferred.

Embedded within clinical operations, the Clinical Trial Assistant owns essential document readiness and compliance checks such as anti-bribery screening, financial disclosure, and denied parties screening across clinical trials. Working closely with study sites, in-house departments, and compliance teams, the Clinical Trial Assistant ensures CTMS records and grant payments remain accurate so submissions stay timely and regulatory follow-up stays on track.

Core Functions

• Assemble and provide support for timely Clinical Trial Submissions and availability of Essential Documents for clinical trials, and create an Essential Documents Repository.
• Assemble and track availability of all essential documentation required for study conduct.
• Provide professional presentation of study materials for investigator/vendor or country operations meetings and document (minutes) project team meetings where need be.
• Liaise with sites and in house departments to ensure appropriate regulatory follow-up.
• Update, maintain and monitor CTMS and clinical and study planning databases to allow accurate project management, regulatory reporting and clinical grants payments.
• Follow up/check final accountability of IMP and return or destruction as appropriate.
• Review study budgets/clinical trial agreements for consistency with study protocol.
• Perform compliance checks, including ABC (anti-bribery + corruption checks) on all HCP (fact finding, workflows, tracking, renewals), denied parties screening (DPS), financial disclosure (check need, track, process letters and documentation) and disclosure agreements, with troubleshooting alongside compliance, technical services etc.
• Manage clinical trial payments and payment tracking, and enter and track payments in GMS (grants management system), run reports, execute payments in COMET (SAP) and purchase orders as needed.
• Maintain trackers, generate and track Trial master file reconciliation of clinical grants/compliance documents, and take on possible SME roles such as CTMS, TMF steward, SIP, CLMS and Safety reporting tracking.

Qualifications & Experience

• Bachelor degree (e.g. medical assistant, or paramedical education) or relevant work experience in clinical research field.
• Understanding and knowledge of study protocols and study working documents, lab manuals, etc.
• Good understanding of the clinical research processes.
• Understanding of the ICH/GCP (international good clinical practice guidelines and harmonization) and local clinical trial regulations.
• Advanced computer skills, e.g. professional use of MS Office programs such as Excel for daily business.
• Ability to build quick basic understanding of SAP COMET, Grants Management System and eTMF (VAULT).
• Advanced communication skills (written and verbal) in French or Dutch AND English.

Reporting to the VP and director of clinical operations, the Clinical Trial Assistant delivers operational support across study conduct, from vendor and site payments to TMF/eTMF filing and shipment of start-up materials. Partnering with study managers and CRAs, the Clinical Trial Assistant maintains tracking systems, correspondence, and meeting records so trials progress on schedule.

Primary Duties

• Process and track payments to vendors and study sites as appropriate.
• Support VP and director of clinical operations, study managers and CRAs in all aspects of the conduct of Clinical Research Trial.
• Maintain multiple tracking systems related to study details, training, and trial metrics.
• Lead sample accessioning efforts as needed.
• Print, assemble and ship start-up materials to investigator sites as needed.
• Track and ship trial equipment, and receive and track returned equipment as required.
• Assist with budget and contract processing and support clinical research managers in sending/processing budget and contract materials.
• Assist with site feasibility activities/non-disclosure agreements and collection of study start-up documents.
• Create and generate study relevant updates/reports through spreadsheets and file documents within the TMF/eTMF.
• Distribute study plans and correspondence to relevant team members, and distribute and track correspondence to investigator sites and study vendors.
• Schedule/coordinate in-house and off-site meetings and training sessions, and attend study team meetings, produce and distribute meeting agenda and minutes.
• Participate in data cleaning, listing, and report output reviews.

Skills & Qualifications

• Bachelor's Degree in life science or equivalent preferred but not required.
• 2+ years experience in a Clinical Research related role within the pharmaceutical/biotech or CRO industry preferred but not required.
• Experience with small molecule drug development preferred but not required.
• Previous clinical work experience that provides the knowledge, skills, and abilities to perform the job.
• Broad knowledge of ICH, GCP, IRB/IEC, and local regulatory authority for diagnostic & assay preferred.
• Experience utilizing CTMS, EDC and related software.
• Proficient knowledge of Microsoft Office Suite and the ability to learn additional necessary software.
• Excellent written and verbal communication skills.
• Ability to multi-task and re-prioritize workflow as necessary.

Sitting at the intersection of clinical trial logistics and document management, the Clinical Trial Assistant builds and maintains Trial Master Files, tracks action items, and coordinates ancillary supplies and meeting logistics for the study team. Operating across contract research organizations, vendors, and internal clinical colleagues, the Clinical Trial Assistant supports ICH-GCP compliance and helps study deliverables land on time.

Duties

• Assist in the operational and logistical aspects of supporting clinical trials according to ICH-GCP and internal procedures.
• Support the clinical trial team, tracking critical information, ensuring that all essential documentation are collected, maintained, and filed during the study.
• Provide support to the clinical trial team in compliance with study plans and company processes.
• Organize agendas, maintain meeting minutes, create materials, and coordinate logistics for internal or external meetings.
• Follow up and track action items through completion.
• Assist with set up and maintenance of Trial Master Files and ensure all relevant study documents are filed and archived based on the appropriate guidelines and processes throughout the conduct of the study.
• Assist in the ordering and managing of ancillary clinical trial supplies.
• Support tracking and maintaining clinical trial insurance.
• Identify areas for process improvements with regards to tasks within the role.
• Liaise with contract research organizations, vendors, and other suppliers of project support services to ensure study deliverables are met, where required.

Minimum Qualifications

• High school diploma or equivalent required, associate degree preferred.
• 0-1 year of industry experience working in the Pharmaceutical, Biotechnology or other related industry required.
• Equivalent experience may be accepted (i.e., Study Coordinator experience).
• Good computer skills required.
• Working knowledge of Outlook, MS Word, Excel, and PowerPoint.
• Experience with MS Teams and Smartsheets is a plus, but not required.
• Ability to work independently and prioritize activities effectively.
• Strong attention to detail and effective time management skills.
• Good communication skills, both oral and written.
• Excellent organizational skills.
• Innovative and creative mindset strongly desired.
• Fluent English required.

A key member of an infectious disease research program, the Clinical Trial Assistant/Program Assistant I delivers participant scheduling, re-consenting, study kit preparation, and chart review using EPIC and REDCap. Collaborating across study coordinators, the Senior Clinical Research Manager, and the Principal Investigator, the Clinical Trial Assistant/Program Assistant I safeguards data credibility and specimen tracking for clinical trials.

Functions

• Assist the study coordinators with scheduling appointments for subjects on clinical trials and re-consenting participants on clinical trials.
• Assist the study coordinators with sample tracking and preparing study kits for a large sample collection study.
• Perform review of medical charts using EPIC and enter data in REDCap, Excel or other study-related databases.
• Perform data entry for case report forms and review data prior to entering to ensure its credibility.
• Assemble and mail out study kits for clinical trials.
• Assist with retrieving and transporting clinical blood specimens from partner medical centers.
• Assist with basic processing and banking of lab specimens and associated record keeping.

Experience & Qualifications

• High school graduation or GED.
• BA/BS in a biological sciences field, or Medical Assistant with experience in chart review and scribing.
• Minimum of one-year experience in a related field.
• Previous experience working with patient medical charts.
• Previous work as a medical scribe or similar experience with medical terminology.
• Experience working with REDCap and Access databases.
• Familiarity with extracting data from a database and with data filtering.
• Competence working with Office Suite, particularly with Excel and PowerPoint, and desire familiarity with REDCap.
• Strong written and verbal communication skills.
• Attention-to-detail.

Timely setup and execution of bioavailability and bioequivalence trials depend on the Clinical Trial Assistant, who delivers logistical support spanning contracting, vendor management, insurance, and archiving. Based within a Clinical Research & Development team of about 10 professionals and reporting to the vice president of Clinical Research & Development and Toxicology, the Clinical Trial Assistant upholds the Clinical R&D Quality Management System.

Accountabilities

• Participate in the many different logistical and operational activities in conjunction with the set-up and execution of the clinical trials including contracting, vendor management, insurance, financial overviews, filing and archiving.
• Assist in the preparation of different types of documents that are being used in the preparation and execution of clinical trials.
• Participate in maintaining the Clinical R&D Quality Management System.
• Assist in the planning, organization and execution of meetings, such as Clinical Trial Team meetings, R&D events, and/or Investigator meetings.
• Work within a team of approximately 10 Clinical Research & Development professionals.
• Report to the vice president Clinical Research & Development and Toxicology.

Technical Qualifications

• A bachelor or master's degree in life sciences or other relevant education.
• Excellent attention to detail, initiative, and planning and organizational skills.
• Ability to work within a team, liaising efficiently with internal departments and third parties.
• Ability to manage a high workload and the pressure of deadlines.
• Good communicator, able to clearly explain to internal and external parties what needs to be done and what is expected.
• Ability to keep all parties involved well-informed and updated.
• Pragmatic and structured approach to work, while open-minded and flexible when required.
• Enjoyment of working in a fast-paced organization.
• A good command of the English language, both in writing and speaking.

As the Clinical Trial Assistant, this role owns the receipt and registration of clinical study samples, recording of clinical data, and quality control of database entries. The clinical studies team relies on this work, alongside coordination with project managers, pathologists, and international clinical centers, to deliver accurate results to monitors and test centers.

Activities

• Receive and register sample material for clinical studies.
• Document and record clinical data.
• Communicate with international clinical centers.
• Assist and monitor in the supervision of clinical studies in cooperation with project managers and pathologists.
• Transmit results to monitor / test centers.
• Record results electronically in databases.
• Perform quality control of database entries.

Position Requirements

• Experience in working on clinical studies as well as data collection and documentation desirable but not a prerequisite, with career changers with professional experience in the field "clinical studies" also welcome.
• Proficiency in handling the MS Office package.
• Structured, responsible and independent way of working.
• Distinct service orientation, confident and friendly demeanor, communicative competence and team spirit.
• Reliability and resilience.
• Very good written and spoken English skills.

Clinical Trial Assistant shapes the logistical coordination of clinical trials under GCP and relevant SOPs, preparing, translating, and filing trial documentation as a pivotal point of contact for the clinical trial team. The work directly supports clinical trial team members through meeting minutes, training tracking, and follow-up on contracts, POs, and invoices, keeping trials compliant and on schedule.

Operational Focus

• Administer, maintain and coordinate the logistical aspects of clinical trials according to GCP (Good Clinical Practice) and relevant SOPs.
• Act as a pivotal point of contact for the clinical trial team.
• Support the clinical trial team in various administrative tasks.
• Prepare, translate, review and file documentation for clinical trials.
• Help process improvement initiatives, including developing SOPs.
• Provide agenda, minutes and action points for meetings.
• Support processes related to setting up and tracking of trainings.
• Follow up on contracts, letters of intent, POs, invoices.

Knowledge Skills & Abilities

• Bachelor's degree in life science or related field.
• At least 2 years of experience in clinical environment.
• Sound knowledge of Windows and MS Office (Word, Excel, Access, PowerPoint).
• Flexible and proactive approach.
• Fluency in English (spoken/written).
• Proficiency in Dutch and French is an absolute must.

The Clinical Trial Assistant oversees eTMF and TMF management for sponsor studies, collating documents from monitors and CROs and drafting study-specific documents for signature. Reporting to Clinical Project Managers in a pharma or CRO environment, the Clinical Trial Assistant tracks project timelines, budgets, and invoices so studies stay organized and on budget.

Key Deliverables

• Oversee and manage the eTMF and organise and maintain the TMFs.
• Collate documents from monitors and/or CROs for sponsor oversight files.
• Assist in setting up clinical study files.
• Create drafts of study specific documents.
• Seek signatures for approved documents.
• Support Clinical Project Managers.
• Arrange cross-functional meetings and distribute minutes.
• Review invoices.
• Assist with the tracking of project timelines.
• Maintain budget tracking tools when required.

Professional Experience

• 1+ years' experience as CTA.
• Experience within a pharma/CRO environment desirable.
• Exposure to timeline and budget tracking.
• Experience with TMF.
• Knowledge of regulatory documents or terminology.
• Ability to multitask and prioritise tasks.
• Good communication skills.

Embedded within Clinical Development and Clinical Operations, the Clinical Trial Assistant develops study trackers and oversees TMF inspection readiness, essential document distribution, and IRB and EC submission documents from start-up through closeout. Working closely with the Global Clinical Trial lead and the Clinical Project Manager, the Clinical Trial Assistant resolves study discrepancies and provides milestone updates that keep programs GCP/ICH compliant and inspection ready.

Areas of Ownership

• Develop and maintain study tools including trackers, spreadsheets, and filing systems for various studies, and contribute to the development of study-related documents and tools.
• Create, maintain, and track information for key study activities and needs (e.g., study contact list, site start-up, enrolment, histological slides, etc.).
• Assist with meeting coordination and preparation activities, including agendas, and take, finalize, and file meeting minutes as needed.
• Assist in Site Qualification and Site Selection Activities and oversee the preparation, distribution and follow-up with investigative sites for essential documents.
• Confirm distribution of safety reports.
• Oversee the ordering, distribution and tracking of trial materials, e.g., eDiaries, lab supplies.
• Provide administrative support to the Clinical Operations Team.
• Provide oversight of regulatory documents required for Local/Central IRB Submissions, EC Submissions, through investigational product greenlight/release to ensure completeness and quality, and review regulatory documents to support site updates to the IND.
• Ensure TMF inspection readiness by assisting with creation of the TMF Index and TMF Plan, conducting periodic TMF document content review for completeness, and assisting with quality reviews of TMF.
• Ensure documents are filed in the correct locations with correct file naming conventions, and assist in the archiving of study documentation for the TMF.
• Assist in tracking milestones, generating study metrics, and providing written and verbal updates to Management.
• Liaise with Clinical Project Manager and/or others to resolve study related discrepancies and issues.
• Ensure adherence to pertinent regulatory requirements and departmental policies, practices and procedures, and ensure the program meets all GCP/ICH Guidelines and is inspection ready, keeping knowledge up to date by reading SOPs and maintaining awareness of GCP guidelines.
• Participate in the development of SOPs, Work Practices and Work Instructions.

Education & Experience

• BS/BA degree or Associates degree in a health-related field (e.g., RN, biological science, or pharmacy or other health related discipline).
• 2+ years' experience in the described contributions.
• Good understanding of principles of good clinical practice.
• Knowledge and experience in overseeing and/or maintaining a TMF.
• Demonstrated computer skills in relevant IRT, EDC and other third-party systems.
• Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems, and ability to work with large databases.
• Demonstrated agility to learn and prioritize multiple responsibilities independently, remove barriers and drive projects to completion.
• Strong oral & written scientific communications skills.
• Good presentation skills for diverse audiences (investigator meetings, site personnel, KOL interactions and internal project teams).
• Ability to strike a balance between independent work and team interaction, and be a team player in a cross-functional team.
• Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships.

Reporting to the lead Clinical Trial Manager, the Senior Clinical Trial Assistant oversees study execution team support, essential document packet and ICF approval processes, and investigational product supply tracking. Partnering with CRAs and supply chain, the Senior Clinical Trial Assistant secures TMF completeness and onboards new CTAs so trials run on time and within budget.

Role Responsibilities

• Support one or more study execution teams (SETs), including scheduling meetings, distributing agendas and meeting minutes.
• Document outstanding action items with expected completion dates and responsible individual(s), and follow up on all SET action items.
• Support SET risk management discussions, follow-up and documentation.
• Track and maintain study information, report on study progress, and disseminate basic study tracking information including, but not limited to, visit reports, regulatory documents, site contact lists, team contact lists and vendor lists.
• Track and provide IRB/IEC submission documentation and other supplementary documentation, as appropriate.
• Obtain, review, process, and track study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.).
• Lead Essential Document Packet review and approval process and ICF development, review and approval process.
• Attend monitoring oversight visits with CRA or CTM, where needed and as appropriate.
• Maintain and ensure the completeness of the Trial Master File (TMF) in accordance with SOP requirements.
• Lead the management and tracking of Investigational Product (IP) supplies for study sites in collaboration with Supply chain, and oversee preparation, shipment and management of study supplies to sites.
• Support preparation of materials for investigator meetings, workshops, and study manuals, and lead development of study newsletters.
• Lead onboarding of new CTA team members.
• Identify and support process improvement initiatives.
• Ensure all work adheres to ICH Good Clinical Practice (GCP) guidelines and complies with company SOPs.

Background & Experience

• Bachelor's degree or equivalent or combination of relevant experience and training.
• 2 to 4 years of relevant industry experience.
• Proficiency in Microsoft Word, PowerPoint and Excel.
• Effective communication skills.
• Excellent organizational skills and attention to detail.
• Excellent problem-solving skills with appropriate and timely escalation.
• Ability to complete activities with minimal oversight and take direction well.
• Ability to build strong relationships with co-workers of various backgrounds and expertise.
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
• Values-based leadership consistent.
• Flexibility and integrity.

Sitting at the intersection of project management and clinical trial administration, the Clinical Trial Assistant produces project status and financial reports, manages purchase orders and study invoices, and organizes team and client meetings. Operating across project managers, project directors, and CRO functions such as clinical operations and biometrics, the Clinical Trial Assistant monitors eTMF filing and training compliance, giving project managers sound financial and operational oversight of studies.

Job Functions

• Organize project team and client meetings including scheduling, creating meeting materials, binders, agendas and meeting minutes, etc.
• Assume project management tasks as assigned by the study project manager/project director with final approval of deliverables completed by the study project manager/project director.
• Organize study information and supplies.
• Generate and maintain organizational charts, team calendar, newsletters, mass mailings, project specific information including but not limited to process flow charts, contact lists, holiday lists, study website, mailing labels.
• Track, dispatch and maintain study supplies following applicable company processes.
• Manage internal and client project reporting.
• Generate and review for accuracy reports to facilitate project status and financial reporting.
• Complete system updates and queries.
• Support project manager with financial tasks.
• Oversee the purchase order process including creating and processing purchase orders and processing study invoices.
• Process Investigator payments when required.
• Support preparation of study files by maintaining and distributing project documents, and ensure documents within the electronic trial master file comply with filing/naming guidelines and have the correct status.
• Use the learning management system to assign project specific training to team members and track training compliance.

Requirements

• BA/BS or equivalent or any relevant and qualifying training.
• Minimum of 3 years of relevant clinical trial experience.
• Robust knowledge of the company's industry and service offerings.
• Working knowledge of relevant regulations and of drug/patient safety procedures and regulations.
• Familiarity with medical terminology.
• Understanding of basic roles within the clinical research organization including but not limited to clinical operations, biometrics, regulatory and drug safety.
• Advanced knowledge of several functional activities, use of functional specific processes or systems, and/or therapeutic knowledge based on previous work assignments.
• Ability to use basic principles of timeline management, project financials, and risk management, with general knowledge of risk management.
• Understanding of project financial management including forecasting and change order development.
• Expert knowledge of applicable systems/processes and proficiency in using applicable business applications including word processing, spreadsheet, presentation programs.
• Passionate and responsible, with the ability to use logic effectively to complete assigned project management tasks.
• Fluent English in reading, writing and speaking, and fluency in host country language.
• Ability to serve as a back up to the project manager in a limited capacity based upon assigned project management tasks.

A key member of the clinical team, the Clinical Trial Assistant advances TMF upkeep, clinical trial supply distribution, and CRF and query tracking while mentoring less experienced CTAs. Collaborating across CRAs and the Regulatory and Start-Up team, the Clinical Trial Assistant serves as a central contact for project communications, helping sites stay compliant and projects meet their timelines.

What You'll Do

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files and completeness.
• Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• Act as a mentor for less experienced Clinical Trial Assistants (CTAs).
• Assist with training and onboarding of new CTAs.
• Serve as subject matter expert for business processes as needed.
• Lead CTA study teams as needed.
• Assist with interviewing and screening of potential new team members as needed.
• Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
• Participate in departmental quality or process improvement initiatives.

Required Qualifications

• High School Diploma or equivalent required.
• 5 years administrative support experience.
• Minimum 2 years clinical research experience strongly preferred.
• Equivalent combination of education, training and experience accepted.
• Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Effective written and verbal communication skills including good command of Spanish and English language.

Efficient study setup, conduct, and closure in cancer diagnosis and treatment research depend on the Clinical Trial Assistant, who develops study materials, trackers, and training resources while coordinating NDAs, CDAs, and site budgets. Serving as a link between the legal team, study sites, and CROs, the Clinical Trial Assistant compiles eTMF and CTMS data for reporting and supports quality review of eCRFs.

Day-to-Day Responsibilities

• Work cross-functionally with the study teams internally and externally and collaborate with the study team to develop study-related materials, trackers, and tools.
• Prepare study-related materials for the training of internal and external staff.
• Work within multiple company systems to create or compile data for reporting and metric purposes (i.e., eTMF, CTMS, legal web site, etc.).
• Coordinate execution of Non-Disclosure and Confidentiality Agreements (NDAs/CDAs) and/or site-specific budgets between the legal team and study sites.
• Review site-specific regulatory packets for completeness and accurately assist sites and/or Clinical Research Organization (CRO) with study supplies management.
• Track site payments and vendor invoices.
• Conduct study closure activities (sites status, reconciliation activities, filing & archiving).
• Assist with meeting coordination, meeting materials and meeting minutes.
• Track and collate clinical trial documentation related to Clinical Study Report (CSR) appendices, as needed.
• Support quality review of electronic Case Report Forms (eCRFs), eTMF and other study-related activities.

Qualifications & Experience

• Bachelor's Degree in biology-related field or equivalent healthcare or laboratory-related work experience.
• At least one year of experience working in clinical research and/or knowledge of Good Clinical Practice (GCP) preferred.
• Background in biology, genetics, and/or medical terminology, with interest in a medical and/or clinical research career.
• General knowledge of computers and navigating databases.
• Proficiency in Microsoft Office suite (Word, Excel, PPT).
• Good interpersonal/communication skills.
• Well organized and team-oriented.
• Drive to make a positive impact in cancer diagnosis and treatment.
• Excellent written and verbal communication skills in English.

As the Clinical Trial Assistant, this role oversees study start-up activities including budget and contract negotiations, ICF revisions, and essential document packages, while leading TMF management and QC reconciliation. The clinical operations team relies on this work to track site activation, enrollment, and start-up metrics alongside Clinical Trial Managers, investigators, and vendors, surfacing trends that improve timelines.

Scope of Work

• Coordinate, guide and assist with start-up activities (budget/contract negotiations, ICF revisions, and essential document packages) both site facing and with the internal cross-functional team.
• Track metrics and study start-up timelines to identify trends and opportunities for improvement.
• Develop and maintain good working relationships with investigators and study staff.
• Track and report on study progress including site activation, patient enrollment, monitoring visits.
• Ensure that all essential study documents are filed appropriately and kept in an organized central repository for the project team.
• Review Site Visit Reports for accuracy, quality, and consistency.
• Lead the management of the TMF, including establishing QC processes and reconciliation of findings.
• Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites.
• Assist Clinical Trial Managers with vendor management activities.

Skills & Qualifications

• BA/BS degree.
• At least 2 years of CTA industry experience (biotech, pharma or device).
• Proficiency in Microsoft Office/Google suite.
• Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF).
• Ability to work effectively under a changing environment.
• Ability to solve problems under pressure.
• Excellent attention to detail and the ability to keep detailed, accurate records.
• Strong written and verbal communication skills.
• Fluency in English with solid writing abilities.

Clinical Trial Assistant refines administrative support for clinical research, from study start-up through site closure, by maintaining site compliance systems, handling clinical documentation, and tracking CRFs and queries. Success in the position means Project Managers, CRAs, and the Clinical Operations Department meet project goals with accurate study files and audit-ready quality management documentation.

Work Activities

• Assist Project Manager and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
• Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for accuracy and completeness.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Assist in preparing Quality management system documentation and preparation for audits.
• Provide general administrative support to the Clinical Operations Department.
• Assist the Clinical teams in completion of all required tasks to meet departmental and project goals.
• Assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.

Requirements

• Degree in medicine, health care, life sciences or related fields.
• Strong general administration skills and experience.
• Basic knowledge of clinical trial processes and ICH/GCP guidelines.
• Proficiency in the use of Microsoft Office.
• Well organized with good time management skills.
• Fluency in English and in the country's native language.

The Clinical Trial Assistant coordinates day-to-day project support and office operations for a growing Clinical Operations team, from sending documents to sites to maintaining tracking databases and scheduling meetings. Reporting to Clinical Operations leadership, the Clinical Trial Assistant aids other departments with ad hoc projects and quality control reviews, helping the company sustain rapid global growth.

Performance Expectations

• Provide day-to-day project support activities such as maintenance of project-related files, sending documents to sites, etc.
• Handle general office organization, including front desk/reception coverage, ordering supplies, faxing, shipping, managing inventory, collaboration with local vendors, etc.
• Perform administrative duties in conformity with company policies and procedures.
• Coordinate and provide meeting minutes, schedule appointments, set up events, and make travel arrangements for staff/visitors.
• Maintain databases/spreadsheets as necessary to facilitate tracking/documentation of departmental activities.
• Conduct quality control reviews of departmental documents as necessary.

Experience & Qualifications

• A high school diploma or equivalent (bachelor's degree preferred).
• At least 1 year of CTA experience would be ideal.
• Knowledge of Microsoft Office programs.
• Attention to detail and excellent oral and written communication skills.
• Proficiency both in local language and English.

Embedded within the Clinical Development department, the Clinical Trial Assistant executes administrative and operational support across all phases of clinical trials, from study files and essential documents to purchase orders and clinical supply inventory. Working closely with sites, vendors, and department staff, the Clinical Trial Assistant communicates project metrics through study trackers and prepares regulatory binders and manuals that keep trials organized and invoices paid on time.

Core Responsibilities

• Create and maintain Study Files (hard-copy and electronic).
• Arrange meetings, assist with travel coordination, and prepare and distribute meeting agendas/minutes.
• Facilitate purchase orders and track clinical supply inventory.
• Assist in processing of invoices, ensuring invoice payments for both sites and vendors.
• Assist in preparation of regulatory binders, study and/or pharmacy manuals.
• Maintain and communicate project metrics via study trackers.
• Collect, track and archive Essential Documents.
• Prepare documents/spreadsheets for data reviews.
• Attend Investigator Meetings and interact with sites and vendors as needed.

Technical Qualifications

• Bachelor's degree or equivalent combination of education and work experience in science related field.
• Proficiency with MS Word, Excel, Outlook, and PowerPoint.
• Ability to work within a team with a service oriented approach.
• Ability to perform routine assignments with general instructions and new assignments with detailed instructions.
• Ability to prioritize and multi-task.
• Flexible and able to adapt to changing priorities.