Key Responsibilities and Required Skills for Clinical Research Coordinator

🎯 Role Definition

The Clinical Research Coordinator (CRC) is the operational backbone of clinical trials, responsible for implementing study protocols, ensuring participant safety and consent, maintaining regulatory documentation, and producing high-quality source and electronic clinical data. The CRC coordinates site activities across multidisciplinary teams, liaises with sponsors and monitors, and proactively manages recruitment, retention, and visit scheduling to achieve study milestones while complying with GCP, FDA, and institutional policies.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Assistant / Clinical Trial Assistant
Medical Assistant or Registered Nurse (RN) transitioning into research
Laboratory Technician or Research Associate with hands-on clinical exposure

Advancement To:

Senior Clinical Research Coordinator / Lead CRC
Clinical Research Manager / Study Manager
Clinical Project Manager or Clinical Operations Manager
Clinical Research Associate (CRA) or Site Manager for multi-site studies

Lateral Moves:

Regulatory Affairs Specialist
Clinical Data Manager
Research Quality Assurance / Audit Specialist

Core Responsibilities

Primary Functions

Oversee day-to-day conduct of Phase I–IV clinical trials at the site level, ensuring all study activities adhere strictly to the approved protocol, Good Clinical Practice (GCP), FDA regulations, and local institutional policies.
Screen and recruit eligible participants by reviewing medical records and applying inclusion/exclusion criteria, conducting pre-screening calls, and coordinating eligibility assessments with investigators.
Perform and document informed consent discussions, obtain written informed consent, answer participant questions about study procedures and risks, and ensure consent forms are properly dated and stored.
Schedule and coordinate all participant study visits, procedures, and follow-ups, including laboratory draws, imaging, ECGs, biopsies, and study-specific assessments to maintain protocol timeline adherence and participant retention.
Collect, process, label, store, and ship biological specimens in accordance with protocol-specific procedures, chain-of-custody requirements, and applicable biospecimen shipping regulations (including IATA when required).
Enter complete and accurate source data into Electronic Data Capture (EDC) systems and study Case Report Forms (CRFs) in a timely manner, reconciling discrepancies and responding to sponsor queries during monitoring.
Maintain trial regulatory binders and site files (e.g., Trial Master File, regulatory binder) with up-to-date IRB correspondence, approvals, CVs, delegations of authority, protocol signatures, and training logs, ensuring audit-readiness.
Monitor and report adverse events (AEs) and serious adverse events (SAEs) per protocol and regulatory timelines: document event details, notify principal investigator, submit notifications to the IRB and sponsor, and support safety follow-up as required.
Prepare for and facilitate sponsor monitoring visits and regulatory inspections by organizing source documents, coordinating staff schedules, and ensuring immediate access to requested records; respond to monitor findings and implement corrective actions.
Coordinate and document investigational product (IP) accountability, including storage conditions, dispensing logs, reconciliation, temperature excursion reports, and controlled substance handling when applicable.
Train and delegate study tasks to site staff, maintain delegation logs, and ensure that delegated personnel receive protocol- and GCP-specific training to perform procedures consistently and compliantly.
Serve as the primary site contact for sponsors, contract research organizations (CROs), and external vendors; coordinate communications, provide status updates, and escalate issues that may impact enrollment or data quality.
Implement and execute recruitment and retention strategies, including community outreach, advertising approval coordination, pre-screening pipelines, and participant engagement activities to meet enrollment targets.
Manage study-related billing and financial documentation in collaboration with research administration and billing compliance teams to ensure proper segregation of research vs. clinical charges and timely invoicing.
Complete timely and accurate source documentation for all study activities including concomitant medications, protocol deviations, physical exams, vitals, and other clinical measurements; ensure audit trail integrity.
Collaborate with laboratory services, imaging centers, and external vendors to schedule tests, ensure adherence to sample processing windows, and resolve discrepancies in lab results or sample handling.
Support protocol amendments, informed consent form (ICF) revisions, and new submissions by preparing document packets for IRB review, tracking approval timelines, and implementing approved changes across study documents and team training.
Perform quality control and source-data verification tasks to identify and correct missing, inconsistent, or erroneous data prior to monitoring visits and database lock.
Maintain strict confidentiality and security of participant records in compliance with HIPAA and institutional policies; manage access to protected health information and encrypted research databases.
Participate in investigator meetings, internal study team huddles, and cross-functional workshops to align site activities with study-wide milestones, troubleshoot operational barriers, and implement best practices.
Coordinate study close-out activities including final regulatory submissions, completion of outstanding queries, IP return/destruction documentation, final data reconciliation, and preparation of site close-out visit materials.
Maintain and document competency through required training modules: GCP, human subjects protection, CPR/first aid (if applicable), and study-specific procedures to ensure high-quality and compliant trial conduct.
Support protocol feasibility assessments and site selection activities by providing historical enrollment metrics, resource availability, and local population insights to sponsors and investigative teams.
Identify opportunities for process improvement in participant flow, data capture, and regulatory documentation and implement SOP updates or local job aids to increase site efficiency and compliance.

Secondary Functions

Assist in drafting SOPs, study manuals, and local workflow documents to standardize operations across the site and ensure consistent regulatory compliance.
Provide input into budget development, cost tracking, and resource planning for site-level study execution in collaboration with research finance and contracts teams.
Contribute to community-facing outreach, education sessions, and stakeholder engagement activities to raise trial awareness and support diverse participant recruitment.
Support data management tasks such as performing source-to-CRF reconciliation, compiling monitoring visit responses, and prepping datasets for data lock or vendor transfer.
Participate in quality improvement and root cause analysis initiatives following audits or CAPA (Corrective and Preventive Action) plans and implement agreed corrective measures.
Provide coverage and cross-training for other research staff during vacations or staffing gaps to maintain study continuity.
Assist principal investigator with manuscript preparation, study reports, and presentation materials by compiling datasets, creating summary tables, and documenting protocol deviations or notable operational outcomes.
Maintain inventory of clinical supplies and investigational products, place orders, and coordinate vendor deliveries to prevent disruptions to participant care and protocol compliance.

Required Skills & Competencies

Hard Skills (Technical)

Good Clinical Practice (GCP) and Human Subjects Protection: demonstrable experience applying GCP principles and navigating IRB requirements for clinical trials.
Informed Consent Process: skilled at obtaining and documenting informed consent, assessing participant comprehension, and managing consent form version control.
Regulatory Documentation & IRB Management: preparing and maintaining regulatory binders, submitting amendments, and tracking approvals and continuing reviews.
Electronic Data Capture (EDC) & CRF Management: proficiency entering and querying trial data in systems such as REDCap, Medidata Rave, Oracle Clinical, or similar EDC platforms.
Electronic Health Record (EHR) Navigation: extracting clinical source data, scheduling visits, and coordinating care through major EHR systems (Epic, Cerner, etc.).
Adverse Event (AE/SAE) Reporting: identifying, grading, documenting, and escalating safety events per protocol and regulatory timelines.
Investigational Product (IP) Management: IP accountability, storage condition monitoring, dispensing logs, and temperature excursion documentation.
Clinical Procedures & Specimen Handling: coordinating phlebotomy, processing and shipping biospecimens, ECGs, imaging coordination, and standardized sample labelling.
Clinical Trial Management Systems (CTMS) & Billing Compliance: use of CTMS for visit tracking and understanding of clinical trial billing and sponsor invoicing processes.
Source Documentation & Data Quality: meticulous source documentation practices and experience performing source-to-CRF reconciliation and query resolution.
Protocol Implementation & Deviation Management: interpreting protocol requirements, documenting deviations, and implementing corrective actions.
Basic Statistical Literacy: ability to understand study endpoints, timelines, and basic data summaries to support quality checks and reporting.

Soft Skills

Exceptional communication: clear, compassionate interactions with participants and effective written communication with sponsors and regulatory bodies.
Strong organizational skills: ability to manage multiple studies, schedules, and competing priorities with reliable attention to detail and follow-through.
Critical thinking and problem solving: quickly identify operational issues and implement pragmatic, compliant solutions.
Team collaboration: effective cross-functional coordination with investigators, nurses, lab, pharmacy, and administrative teams.
Time management and prioritization: meet enrollment targets and data deadlines while balancing participant safety and regulatory requirements.
Cultural sensitivity and patient-centered approach: respectful engagement with diverse populations, maintaining trust and confidentiality.
Resilience and adaptability: maintain performance in fast-paced, changing regulatory and operational environments.
Teaching and mentoring: ability to train new staff, delegate responsibilities, and document training outcomes.
Professional integrity: strong ethics in data reporting, participant confidentiality, and regulatory compliance.
Attention to detail: meticulous record-keeping, source documentation, and audit preparation skills.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in Nursing, Biological Sciences, Public Health, Health Sciences, or related field; or equivalent clinical certification with relevant experience.

Preferred Education:

Bachelor of Science in Nursing (BSN), Master's degree in Clinical Research, Public Health, or related discipline; formal certification such as CCRC/CCRA (ACRP) or SoCRA certification preferred.

Relevant Fields of Study:

Nursing (RN, BSN)
Biology / Biomedical Sciences
Public Health / Health Administration
Clinical Research / Clinical Trials Management
Pharmacology or related allied health fields

Experience Requirements

Typical Experience Range: 1–5 years of clinical research coordination experience; 0–2 years acceptable for entry-level positions with strong clinical background.

Preferred:

2–4+ years coordinating clinical trials (Phase I–III) in an academic medical center, hospital, or CRO setting.
Demonstrated experience with FDA-regulated studies, GCP, IRB submissions, and EDC systems.
Prior experience managing investigational product, specimen logistics, and multi-visit participant scheduling.
Experience interacting with sponsors, CRAs, and supporting monitoring or audit activities.

If you want, I can tailor this CRC job description further to a specific therapeutic area (oncology, cardiology, CNS), seniority level (entry, senior, lead), or regulatory environment (academic vs. industry).