Clinical Trial Coordinator Job Description

A Clinical Trial Coordinator keeps an investigator's study running as the protocol requires. In academic medical centers and hospital research departments, the position sits under the principal investigator and turns an IRB-approved protocol into enrolled participants and complete case report forms. That is harder than it sounds. Human subjects regulations and ICH-GCP apply to every consent signature and every adverse event report, and the coordinator carries that compliance day to day while a Clinical Research Associate only verifies it at periodic monitoring visits.

As the Clinical Trial Coordinator, you safeguard participant safety and data integrity on investigator-led studies so that trial results can withstand sponsor review and regulatory inspection. You work under the general supervision of the principal investigator and alongside a project manager, carrying one or more active protocols from site start-up through close-out within an academic or hospital research team.

Career Impact: Coordinating greater-than-minimal-risk interventional protocols gives you the documented hours that SoCRA and ACRP certification pathways require.

Business Impact: Accurate adverse event reporting and prompt query resolution let principal investigators keep IRB approval and publish findings that hold up to scrutiny.

Growth Opportunity: Hands-on work with protocol amendments and trial risk assessments prepares you for Clinical Research Associate or Clinical Project Manager positions.

Company Value: Research hospitals in this segment often support coordinators in pursuing educational opportunities and learning directly from experienced clinicians and trialists.

• Coordinate day-to-day conduct of interventional protocols under principal investigator direction to ensure adherence to ICH-GCP and IRB approvals.
• Lead participant recruitment, screening, and enrollment, including obtaining informed consent in line with protocol requirements.
• Record research data in case report forms and resolve queries to keep study databases accurate and timely.
• Report adverse events, serious adverse events, and protocol deviations promptly to investigators, sponsors, and ethics committees.
• Maintain regulatory binders, essential documents, and study files within institutional and sponsor requirements for audit readiness.
• Liaise with site staff, clinic teams, and community partners to resolve monitoring findings and trial logistics issues.
• Prepare protocol amendments, progress reports, and meeting materials for funders, sponsors, and regulatory authorities.
• Support internal and external audits and inspections to protect research participants and reduce organizational risk.

• Bachelor's degree in a health-related, biological, or scientific field or equivalent work experience.
• 1 or more years of human subjects research experience, with hands-on recruitment, data collection, or study visit tracking.
• Working knowledge of ICH-GCP and local and national regulations governing human subjects research and clinical trials.
• Solid understanding of study protocols, informed consent processes, and adverse event reporting requirements.
• Ability to manage multiple studies, tasks, and priorities independently under general supervision.
• Strong attention to detail in data collection, documentation, and query resolution.
• Clear written and verbal communication with investigators, participants, and site staff.
• Proficiency with office productivity software and research databases for tracking visits and study data.

• Clinical research certification through SoCRA or ACRP, or documented progress toward eligibility for one.
• Experience coordinating greater-than-minimal-risk interventional or therapeutic protocols in a hospital or academic research setting.
• Familiarity with electronic data capture, clinical trial management, and electronic health record systems used in study conduct.
• Supervisory or project management experience, including training site staff or community-based recruitment liaisons.

• Enrollment rate against target, showing recruitment and screening performance.
• Informed consent documentation error rate, reflecting consent accuracy per protocol.
• Median days to resolve data queries, measuring case report form timeliness.
• Percentage of serious adverse events reported within required regulatory timelines.
• Audit and monitoring findings per visit, reflecting regulatory binder readiness.
• Protocol deviations per enrolled participant, tracking adherence to study procedures.

• Base Salary Range: $48,000 to $66,000 annually, depending on experience and certification.
• Bonus: Typically none, with occasional merit or retention awards in hospital systems.
• Equity: Not offered in academic medical centers or nonprofit hospitals.
• Health Benefits: Medical, dental, and vision coverage, plus 403(b) retirement plan with employer match.
• PTO: 15 to 25 days annually, plus paid institutional holidays.
• Common Perks: Tuition assistance, certification exam reimbursement, and paid research training courses.

Because this position involves direct contact with patients and research participants, any offer is contingent on a successful background check and drug screening. All qualified applicants will receive consideration without regard to any characteristic protected under federal, state, or local law. Applicants who need a reasonable accommodation during the hiring process may request one at any time. Candidates must be authorized to work in the United States.

The Senior Clinical Trial Coordinator leads the coordination and administration of multiple medical device studies, from Trial Master File upkeep to study payments, while mentoring junior Clinical Affairs staff. Reporting to the Director of Clinical Projects within Clinical Affairs, the coordinator works with investigators, legal staff, and Finance to keep trials audit ready and on budget.

Key Responsibilities

• Coordinate and support activities for multiple studies under the direction of the Dir. Clinical Projects.
• Assist the Clinical Affairs team with development of study specific documents and with site training (e.g. onsite or remote) on the electronic data capture (EDC) system or protocol as needed.
• Set up, maintain, and archive the Trial Master File (TMF), and collect and track regulatory documents for multiple studies to ensure completeness of TMF and audit readiness.
• Support drafting of the Clinical Trial Agreement (CTA) and budget, and request study specific Confidential Disclosure Agreements (CDA).
• Create study specific Regulatory Binders and ship them to clinical sites.
• Manage all aspects of study specific payments (e.g. vendors, sites) in accordance with executed agreements and approved budgets, track payments and expenses against the department’s budget, and regularly interface with the Finance Department on study accruals.
• Communicate with principal investigators, hospital research, and legal staff to coordinate execution of a study.
• Provide support for study specific meetings (e.g. investigator, core teams, data safety monitoring board (DSMB)), draft and circulate meeting minutes, and assist in remote and/or on site study monitoring.
• Design and update study specific newsletters and circulate the final document to sites.
• Handle study device/equipment shipments, accountability, and reconciliation.
• Maintain Sunshine Act reporting records for assigned studies, report updates to the Transparency Reporting team as needed, and ensure compliance to applicable clinical study regulations and company SOPs, WIs, and policies.

Required Qualifications

• Associates or Bachelor’s degree in a scientific, healthcare, or business related field preferred.
• Minimum of one year of experience working for a medical device/biotech/pharmaceutical company, preferably in a Medical Affairs-related function.
• Some experience organizing and analyzing data preferred.
• Proficiency with Microsoft Office and electronic data capture (EDC) systems.
• Well organized, detail oriented, and accountable.
• Flexible, self-motivated, and able to work well under pressure in a dynamic environment.
• Ability to support multiple projects for Clinical Affairs teams at different locations.

Embedded within clinical operations, the Clinical Trial Coordinator delivers essential document management, CTMS upkeep, and grants payment processing that keep clinical trial submissions timely and compliant. Working closely with sites, compliance, and in-house departments, the coordinator supports anti-bribery checks, financial disclosure, and regulatory follow-up that protect study integrity and audit readiness across every study.

Core Functions

• Assemble and provide support for timely Clinical Trial Submissions and availability of Essential Documents for clinical trials, and create the 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 organize and document (minutes) project team meetings where needed.
• Liaise with sites and in house departments to ensure appropriate regulatory follow-up.
• Update, maintain, and monitor CTMS to allow accurate project management, regulatory reporting, and clinical grants payments, and update clinical and study planning databases.
• 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 ABC (anti-bribery + corruption checks) on all HCP (fact finding, workflows, tracking, renewals), troubleshoot with compliance, technical services, etc., handle financial disclosure (check need, track, process letters and documentation), and conduct denied parties screening (DPS).
• Handle clinical trial payments and payment tracking, enter and track payments and run reports in GMS (grants management system), execute payments in COMET (SAP), and raise purchase orders as needed.
• Generate and track Trial master file reconciliation of clinical grants/compliance documents and maintain trackers.

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 clinical research processes, 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 for daily business, especially Excel.
• Ability to build quick basic understanding of SAP COMET, Grants Management System, and eTMF (VAULT).
• Advanced written and verbal communication skills.
• Advanced communication in local languages and English.

Reporting to the principal investigators, the Clinical Trial Coordinator leads subject recruitment and oversees site liaisons at 12 church-based recruitment sites for a community clinical trial. Partnering with investigators and church leadership, the coordinator keeps research activities compliant with human subjects regulations and helps the trial reach its enrollment goals.

Primary Duties

• Identify, train, and oversee site liaisons at 12 ethnically diverse churches that are the primary recruitment sites for the trial.
• Report to the principal investigators and work in collaboration with the investigators and the leadership of a ministerial alliance and its member churches.
• Provide primary oversight of research activities and assist the project investigators with project management, coordination, and regulatory compliance across internal and external sites while adhering to all regulations regarding studies that involve human subjects’ research and clinical trials.
• Lead subject recruitment and subject database development and management.
• Provide logistical and administrative support to include data collection, tracking and reconciling of study visits and budgets, apply advanced knowledge of study protocols and guidelines, and implement procedures as specified.
• Develop and oversee the implementation of best practice guidelines for conducting the clinical trial.
• Perform recruitment and data collection as needed.

Skills & Qualifications

• Bachelor’s degree in health-related or scientific field.
• 1 to 2 years of human subjects research-related work experience.
• Supervisory experience and experience working within church organizations preferred.
• Leadership and project management skills.
• Database and Qualtrics experience preferred.
• Ability to independently manage workflow and priorities across multiple tasks, people, and responsibilities.
• Excellent organizational and time-management skills, strong attention to detail, and ability to work as a team member.
• Strong verbal and written communication abilities.

Sitting at the intersection of clinical monitoring and document administration, the Clinical Trial Coordinator delivers accurate Trial Master File updates, supply tracking, and Case Report Form management for the clinical team. Operating across project communications as a central contact for CRAs and the Regulatory and Start-Up team, the coordinator helps track site compliance and performance within project timelines.

Duties

• 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.
• Assist the clinical team with 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 completeness.
• Assist CRAs and RSU with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with 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.
• Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training when needed.

Requirements

• High School Diploma or equivalent (required).
• 3 years administrative support experience, or equivalent combination of education, training, and experience.
• Awareness 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 working knowledge of Microsoft Word, Excel, and PowerPoint.
• Written and verbal communication skills.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Good command of English language.

A key member of the clinical projects team, the Clinical Trial Coordinator builds and maintains organized Trial Master File records across multiple studies. Collaborating across departments, research personnel, and consultants on trial logistics, the coordinator supports study reporting and adherence to FDA Good Clinical Practice guidelines.

Functions

• File, organize, and maintain clinical study documents related to the clinical Trial Master File (TMF) for multiple clinical projects.
• Assist in compiling documents and preparing study reports.
• Maintain a high level of professional expertise through familiarity with regulatory guidelines of FDA and other health agencies on Good Clinical Practices, ethical compliance, and safety reporting.
• Interface with various departments, study research personnel, independent consultants, and other in-house managers on trial logistics.
• Cross-train on multiple projects and provide backup when needed.

Experience & Qualifications

• Bachelor's Degree in Biology, Nursing, or a related field preferred.
• 1+ year experience in human clinical trials research, or in the medical devices/pharmaceutical industry, or an equivalent combination of education and experience preferred.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Strong oral, written, and interpersonal communication skills.
• A knack for organization, with ability to prioritize assignments while handling various projects simultaneously.
• A love of science and health care.

Reliable, compliant research data depends on the Coordinator, Clinical Trial, who owns day-to-day coordination of complex interventional protocols, from informed consent to adverse event reporting. Serving under the direction of the principal investigator and supervisor, the Coordinator, Clinical Trial works with clinic staff to protect participants and reduce organizational risk during audits and inspections.

Accountabilities

• Coordinate complex clinical research protocols with direction from the principal investigator and/or supervisor in compliance with regulatory and internal guidelines, including assisting in the development and design of research data collection tools, working with clinic staff to ensure ease of research project implementation, and project start up.
• Deliver the study intervention that may include obtaining patient informed consent and other specific protocol tasks as appropriate.
• Coordinate day-to-day progress of research studies in collaboration with the investigator and/or site supervisor.
• Record research data in case report form, if required, and document and report adverse events.
• Monitor and follow up on research subjects.
• Document all research subject visits, site visits, and study meetings.
• Manage, monitor, and report research data to maintain quality and compliance, and assure timely and accurate data handling.
• Assist in data quality monitoring and in designing data collection or abstraction forms.
• Maintain regulatory binders, if required.
• Assist with internal/external compliance monitoring and/or audits and inspections to protect research participants, assure operational effectiveness, and reduce risks to the organization.
• Communicate with the project manager or investigator and supervisor regarding study task progress.

Technical Qualifications

• High School Diploma or General Education Development (GED) required, and Bachelor's degree OR (4) years of experience in a directly related field.
• Master's degree.
• Preference given to candidates with clinical research certification such as SoCRA or ACRP.
• Minimum (3) years of experience as a clinical research coordinator working with patients and/or research participants.
• Prior experience working with electronic health records.
• Proficient in medical terminology.
• Familiarity with database software.
• Effective written and verbal communication skills and excellent interpersonal skills.
• Ability to multitask, plan, organize, and prioritize projects, and to work independently.

As the Clinical Trial Coordinator, this role delivers day-to-day administrative support for one or more clinical trials, including site document collection, query resolution, and database upkeep. The trial operations team relies on this work, alongside the Project Manager, to complete each project in line with protocol, regulatory requirements, and sponsor standards.

Activities

• Identify and initiate communications with sites to obtain all relevant documents for project/trial.
• Advise research sites on protocol conduct and interpretation of protocol, and ensure resolution of issues.
• Evaluate the quality and timeliness of data entry, issue, track, and resolve queries, and implement corrective action plans as needed.
• Identify issues/trends that require escalation to management and provide input to resolution as appropriate.
• Update and maintain internal databases, tracking systems, project plans, and study files.
• Prepare presentation materials for internal and external meetings, and draft meeting agendas and minutes.
• Work with the Project Manager to support trial processes and distribution of information and reports to monitors both domestically and internationally.
• Facilitate the implementation and ongoing process improvement of established policies and procedures for department/project/trial, and comply with applicable SOPs.
• Maintain department service standards, with particular attention to person/behavioral, staff teamwork, and customer-staff interacting guidelines as outlined in the organization's Code of Conduct.
• Demonstrate and maintain knowledge of regulations, clinical research conduct, laws, guidelines, and standards relating to department/trial(s).

Position Requirements

• Bachelor's degree.
• 1 to 2 years of research-related work experience.
• Familiarity with drug development, clinical research processes and documentation (study start up, maintenance phase, and study close out procedures) preferred but not required.
• Familiarity with EDC and CTMS systems preferred.
• Proficiency in MS Office products (Outlook, Word, Excel, and PowerPoint) and familiarity with databases.
• Proficiency in Adobe Acrobat applications preferred but not required.
• Highly detail oriented, customer service oriented, with strong initiative and a can-do attitude.
• Excellent organizational skills and ability to manage multiple tasks concurrently and prioritize work appropriately.
• Solid written and verbal communication skills and ability to communicate effectively in a matrix environment.
• Strong sense of accountability and ability to work autonomously and as a team player.
• Ability to demonstrate professionalism and willingness to ask questions when in doubt.

Clinical Trial Coordinator shapes the development, execution, and reporting of medical device trials, leading study documentation, feasibility assessment, and site selection. The work directly supports the device project team, where the coordinator serves as the clinical representative and works with relevant managers to maintain data quality, timelines, and regulatory compliance.

Operational Focus

• Work closely with the device project team and provide input to the overall project from a Clinical perspective.
• Lead all aspects of and contribute to the development of study specific documentation e.g. CPSP and CPSRs, ethical approval, case report forms (CRF), data management plan, monitoring plan, project specific training plan, data review plan, statistical analysis plan, etc.
• Supervise set-up and maintenance of the study and manage the study in line with required timelines.
• Ensure compliance with the protocol, country regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures.
• Lead risk assessment and identify risk mitigation strategies at the study level.
• Manage feasibility assessment to select relevant regions and countries for the study, and conduct site evaluation and selection.
• Lead investigator meeting preparation and execution.
• Monitor progress for site activation and act on any deviations from the CPSP.
• Supervise monitoring of the study, attend monitoring visits as required, and raise issues related to study conduct, quality, and timelines with relevant managers.
• Ensure data quality including regular review of data and protocol deviations.
• Supervise study close-out activities and contribute to clinical study report writing and review.

Knowledge Skills & Abilities

• MSc in Microbiology/Molecular science or related field.
• PhD in Microbiology/Molecular science or related field.
• Project Management experience.
• Experience working in a regulated environment.
• Prior experience as trial/study manager.
• Strong communication skills and excellent organisation and interpersonal skills.
• Ability to manage multiple priorities, work independently, prioritise, and work within a team environment.

The Clinical Trial Coordinator advances the set-up and running of several studies by maintaining trial documentation, preparing protocol amendments, and supporting safety reporting to ICH-GCP. Reporting to the Project Lead within the trials portfolio team, the coordinator liaises with site staff to resolve queries and keeps regulatory approvals current.

Key Deliverables

• Maintain and update trial documentation, including trial specific procedures and case report forms (CRF), and ensure sites have all essential documents.
• Ensure all current regulatory requirements are met and approvals are obtained.
• Produce reports as required by the funder, Sponsor, ethics committee, and regulatory authorities, and produce regular trial updates/newsletters etc. to sites.
• Ensure biological samples are sent to central laboratories.
• Prepare protocol amendments for approval, as required, and disseminate them to sites.
• Perform data collection and entry.
• Ensure adherence to the protocol and respond to queries about the trial.
• Ensure prompt reporting of suspected unexpected serious adverse reactions and serious adverse events from sites and obtain all relevant information.
• Prepare and maintain a trial risk assessment and monitoring plan.
• Liaise with site staff to resolve queries raised during monitoring visits.

Professional Experience

• Graduate in biological science or allied health field.
• Previous experience in clinical trial research.
• Experience of existing national clinical research structures, regulatory and ethical systems.
• Some experience of developing and maintaining clinical trial documentation (i.e. protocol, patient information sheets and case report forms).
• Understanding of GCP and knowledge of local and national clinical trial regulations.
• Some experience of the Integrated Research Application System (IRAS) / CWOW.
• Demonstrable IT skills.