Job Description
Position Overview
The Clinical Research Coordinator is responsible for coordinating and overseeing all aspects of participant care and study execution from screening through study closeout. This role ensures compliance with study protocols, Good Clinical Practice (GCP), and federal regulations while prioritizing participant safety, data integrity, and high-quality patient care.
Key Responsibilities
- Coordinate all aspects of participant care from screening through study completion in accordance with the study protocol and Principal Investigator (PI) delegation.
- Ensure the informed consent process is conducted and documented in compliance with federal regulations (45 CFR Part 46).
- Maintain accurate and up-to-date source documentation, including medical history collection, eligibility assessments, and documentation of all study-related procedures.
- Promptly identify, document, and report adverse events, protocol deviations, and unanticipated problems to the PI, sponsor, and IRB in accordance with 21 CFR Part 312.
- Provide individualized, protocol-based education to study participants regarding informed consent, study requirements, investigational product (IP) use, safety considerations, potential side effects, and participant rights.
- Facilitate timely and accurate communication of participant information with the PI and research team to support study conduct and patient safety.
- Maintain strict adherence to HIPAA regulations and protect participant confidentiality at all times.
- Dispense, administer, and educate participants on the proper use of investigational products in accordance with the protocol, scope of practice, and PI direction.
- Collaborate closely with the clinical team and external clinical partners to support trial implementation and ensure protocol compliance.
- Perform accurate and timely data collection, source documentation, and data entry into sponsor Case Report Forms (CRFs), Interactive Web Response Systems (IWRS), and databases. Resolve data queries and sponsor requests promptly.
- Assist with long-term storage and maintenance of research records in accordance with contractual and regulatory requirements.
- Prepare for and participate in site initiation visits, monitoring visits, audits, and regulatory inspections.
- Maintain Essential Documents and the Trial Master File (TMF), ensuring regulatory compliance and audit readiness, including FDA Form 1572, financial disclosures, IRB documentation, delegation of authority logs, monitoring reports, and enrollment logs.
- Support coordination with internal and external stakeholders, including sponsors and CROs, to facilitate study start-up, patient recruitment, enrollment goals, and trial execution.
- Promote a patient-centered research culture that emphasizes safety, quality, and ethical conduct.
- Manage participant stipend payments, including system registration and ongoing payment processing in accordance with company policies.
- Adhere to company research quality assurance standards and operating procedures.
- Travel as required to investigator meetings, sponsor meetings, and between facilities or practices within the community.
- Maintain current knowledge of clinical research regulations and standards, including GCP, FDA regulations, HIPAA, and IATA shipping requirements, and maintain required licensures and certifications.
- Provide training and oversight to Clinical Research Coordinators and/or Research Assistants as assigned.
- Actively promote GUEST customer service standards and foster effective working relationships across all levels of the organization.
- Participate in team initiatives, staff meetings, and perform duties in accordance with company policies and procedures.
- Maintain regular and reliable attendance.
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