Key Responsibilities and Required Skills for Clinical Trials Coordinator

🎯 Role Definition

A Clinical Trials Coordinator (CTC) manages day-to-day clinical study operations at investigational sites or within sponsor/CRO teams. The CTC ensures clinical trials are conducted according to protocol, ICH-GCP guidelines, and local regulatory requirements, coordinates study visits and subject recruitment, maintains accurate source documentation and eCRFs, interfaces with investigators and monitors, and supports safety reporting and regulatory submissions. The ideal candidate combines strong clinical research knowledge with excellent communication, organizational skills, and proficiency in CTMS/eCRF systems.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Assistant / Research Assistant
Medical Assistant / Licensed Practical Nurse / Registered Nurse (entry-level clinical roles)
Laboratory Technician or Clinical Data Coordinator

Advancement To:

Senior Clinical Trials Coordinator / Lead Coordinator
Clinical Research Associate (CRA) / Field Monitor
Clinical Trials Manager / Study Manager
Clinical Project Manager or Clinical Operations Manager

Lateral Moves:

Regulatory Affairs Specialist
Clinical Data Manager
Patient Recruitment Specialist
Quality Assurance / Compliance Specialist

Core Responsibilities

Primary Functions

Coordinate and oversee day-to-day clinical trial activities at the study site(s), including scheduling subject visits, ensuring protocol compliance, and maintaining study binders and regulatory files in accordance with ICH-GCP and institutional policies.
Manage informed consent process: conduct consenting visits, document consent, answer participant questions, and ensure consent forms are updated and approved before use.
Screen, recruit, enroll, and retain study participants by implementing recruitment strategies, pre-screening potential subjects, obtaining eligibility documentation, and tracking enrollment metrics.
Prepare and maintain essential regulatory documents (IRB/EC submissions, amendments, continuing reviews, approvals, and correspondence) and ensure timely submission to institutional review boards and ethics committees.
Support study start-up activities including site feasibility assessments, site initiation visits, investigator training, and coordination of study supplies, equipment, and investigational product.
Collect, verify, and enter clinical trial data into eCRF/CTMS systems accurately and timely; perform source document verification (SDV) and ensure completeness of source notes.
Monitor and document adverse events (AEs), serious adverse events (SAEs), and safety signals; ensure timely reporting to sponsor, IRB, and regulatory authorities per protocol and local regulations.
Coordinate sample handling and shipping logistics for laboratory specimens, ensuring chain-of-custody, appropriate labeling, cold-chain requirements, and lab requisitions are followed.
Facilitate communication between investigators, study staff, sponsor/CRO monitors, and external vendors; schedule and support monitoring visits and audits while providing complete access to trial documentation.
Maintain investigational product accountability: receipt, storage, dispensing, reconciliation, temperature logs, and destruction according to protocol, sponsor SOPs, and applicable regulations.
Execute source documentation of clinical assessments, concomitant medications, procedures, and protocol deviations; escalate and document protocol deviations and corrective actions.
Prepare and track study budgets, reimbursements, and subject stipend distribution; work with finance and contracting teams to ensure timely invoicing and budget compliance.
Coordinate training for site staff on protocol-specific procedures, safety reporting, GCP, and study-specific eCRF or CTMS tools; maintain training logs and delegations of authority.
Conduct periodic quality checks of study documentation, data queries, and regulatory files to maintain inspection readiness and data integrity for sponsor audits and regulatory inspections.
Participate in study close-out activities including final source data reconciliation, archival of regulatory binders, return or destruction of investigational product, and final site close-out visit coordination.
Implement and maintain patient confidentiality and HIPAA-compliant documentation processes; secure storage and limited access to identifiable participant information.
Support protocol amendments implementation by coordinating updated materials distribution, training, and documenting implementation dates at the site level.
Maintain and update recruitment tracking logs, screening and enrollment logs, and other study-specific tracking tools to support trial metrics and reporting to the sponsor.
Assist in development, review, and maintenance of case report forms (CRFs), source document templates, and site-specific SOPs to streamline data capture and operational processes.
Participate in internal meetings, weekly project team calls, and cross-functional working groups to provide site-level status, recruitment forecasts, and risk mitigation plans.
Ensure compliance with local and national reporting requirements for device or drug trials, including expedited safety reporting and periodic safety update submissions.
Support electronic health record (EHR) queries and data extraction activities; coordinate with clinical IT and medical record departments to obtain source data and relevant patient information.

Secondary Functions

Support site-level quality improvement initiatives and contribute to root cause analyses following deviations or audit findings.
Assist clinical operations teams by preparing study metrics dashboards, enrollment forecasts, and site performance reports.
Provide ad-hoc support for feasibility assessments, protocol reviews, and budget negotiations by offering site-level operational input.
Mentor and train junior research staff and research volunteers on day-to-day study execution, informed consent best practices, and documentation standards.
Collaborate with patient advocacy groups and community outreach programs to improve recruitment diversity and retention.
Participate in SOP creation or updates to reflect evolving regulations, sponsor requirements, or institutional policies.
Support data management efforts by responding to data queries, providing clarifications, and facilitating timely query resolution.
Help coordinate investigator-initiated trial activities, grant reporting, and documentation required for institutional oversight.

Required Skills & Competencies

Hard Skills (Technical)

Good Clinical Practice (GCP) knowledge and application — demonstrated ability to conduct trials per ICH-GCP guidelines.
Regulatory and IRB coordination — preparing submissions, amendments, continuing reviews, and maintaining regulatory binders.
Clinical Trial Management Systems (CTMS) — experience with systems such as Veeva, Oracle Siebel, Medidata CTMS, or similar.
Electronic data capture / eCRF proficiency — experience with Medidata Rave, REDCap, or similar eCRF tools and accurate eCRF entry.
Source Document Verification (SDV) and data reconciliation — ability to resolve queries and ensure data integrity between source and CRF.
Adverse Event (AE/SAE) reporting and safety surveillance — experience documenting and reporting safety events per protocol and regulatory timelines.
Investigational product handling and accountability — inventory management, temperature monitoring, dispensing logs, and returns/destruction.
Clinical measurements and protocol procedures — ability to perform or coordinate clinical assessments, sample collection, and clinical testing per protocol.
Microsoft Office and collaboration tools — advanced Excel for tracking, Word for study documents, Outlook/Teams for communications.
HIPAA and data privacy compliance — protecting participant confidentiality and secure handling of PHI.
Basic medical terminology and clinical background — ability to read charts, understand lab results, and communicate with clinical staff.
Project coordination and site start-up experience — managing timelines, training, and site initiation activities.

Soft Skills

Exceptional organizational skills and attention to detail to manage competing priorities across multiple studies and complex documentation.
Strong written and verbal communication skills for clear interactions with sponsors, investigators, IRBs, and participants.
Problem-solving and critical thinking — ability to identify operational risks, propose mitigation strategies, and implement corrective actions.
Empathy and patient-focused mindset to build rapport with participants and support retention and adherence to study visits.
Time management and prioritization — delivering high-quality outputs within tight regulatory and sponsor timelines.
Team collaboration and stakeholder management — working cross-functionally with clinical, data, regulatory, and finance teams.
Adaptability and resilience — comfortable with changing protocols, fast-paced environments, and regulatory updates.
Ethical judgment and integrity — maintaining compliance with research ethics, informed consent standards, and confidentiality.

Education & Experience

Educational Background

Minimum Education:

Associate degree in a healthcare-related field (nursing, clinical research, medical technology) or equivalent clinical experience.

Preferred Education:

Bachelor’s degree in Nursing, Life Sciences, Health Sciences, Public Health, or Clinical Research.

Relevant Fields of Study:

Nursing (RN/BSN)
Clinical Research / Clinical Trials Management
Biology / Biochemistry
Public Health / Health Sciences
Pharmacology / Pharmaceutical Sciences

Experience Requirements

Typical Experience Range: 1–5 years clinical research or related healthcare experience (site-based or sponsor/CRO roles).

Preferred:

2+ years as a Clinical Trials Coordinator, Research Coordinator, or Clinical Research Associate with demonstrable site management, eCRF/CTMS experience, and regulatory submission experience.
Prior experience working with IRBs, investigational product handling, and safety reporting in industry-sponsored or investigator-initiated trials.
Certifications such as ACRP-CRC, SOCRA, or CCRC are a plus.