Clinical Research Coordinator

Description

Clinical Research Coordinator (CRC)

The Clinical Research Coordinator (CRC) is responsible for overseeing and managing the daily operational activities of assigned clinical research studies. This role works closely with investigators, clinical staff, study participants, sponsors, and CROs to ensure that all research activities are conducted in compliance with study protocols, regulatory requirements, and ethical standards.

The CRC serves as the primary owner of study coordination, documentation, data management, and sponsor communication, supporting compliant trial execution from study start-up through close-out.

Key Responsibilities

Study Management & Coordination

• Organize, plan, and coordinate all aspects of assigned clinical trials from initiation through close-out.
• Support study start-up activities including feasibility, regulatory submissions, and site activation.
• Attend investigator meetings, site initiation visits, and other study-related meetings.
• Manage visit schedules and coordinate study-related activities across clinical teams.

Recruitment, Enrollment & Consent

• Collaborate with recruitment teams to support participant screening and enrollment.
• Conduct informed consent discussions with participants, ensuring understanding of study requirements and documentation of consent.
• Ensure protocol and regulatory requirements are met throughout the enrollment process.

Clinical Oversight & Subject Monitoring

• Monitor and assess study subjects in accordance with protocol requirements.
• Identify, document, and report adverse events in collaboration with the Principal Investigator and clinical staff.
• Escalate safety concerns and protocol issues to the PI, sponsor, and IRB as required.

Documentation, Data & Systems

• Maintain accurate and complete source documentation, case report forms, regulatory files, and study records.
• Enter study data into EDC and other required systems and manage study databases.
• Complete, verify, and resolve case report forms and sponsor or monitor queries in a timely manner.
• Report protocol deviations to the PI, sponsor, and IRB as required.

Investigational Product & Specimen Management

• Manage investigational product accountability records and documentation.
• Collect, process, package, and ship study specimens per protocol requirements.
• Perform phlebotomy and handle biological specimens in accordance with study protocols and safety guidelines, when trained and authorized.

Quality, Compliance & Team Support

• Ensure all study activities comply with SOPs, GCP, and regulatory requirements.
• Support quality assurance activities and audit readiness.
• Provide assistance and mentorship to fellow coordinators as needed.
• Maintain strict confidentiality of participant and study information.

Communication & Outreach

• Serve as the primary point of contact for sponsor and CRO communications.
• Participate in occasional outreach or community events related to clinical trials.
• Ensure timely, accurate communication of study updates and issues.

Additional Responsibilities

This job description outlines the primary responsibilities of the Clinical Research Coordinator but is not exhaustive. Additional duties may be assigned as needed to support study requirements, operational needs, and organizational priorities. Responsibilities may evolve based on protocol complexity and business needs.

Requirements

Knowledge, Skills, and Abilities

• Strong leadership and communication skills

• Exceptional organizational and multitasking abilities

• High attention to detail and commitment to regulatory compliance

• Ability to work independently and collaboratively in a multidisciplinary environment

• Strong time management and operational efficiency skills

• Proficiency with office equipment and study-specific systems

• Ability to maintain strict confidentiality

Required Experience & Qualifications

• Education: Bachelor’s degree in a related field

• Experience: Minimum of two (2) years of clinical research or clinical trial management experience

• Preferred Credentials: Medical certification or licensure (e.g., MS, LPN, RN)

• Phlebotomy: Prior experience performing blood draws and handling biological specimens required