Clinical Research Coordinator
Specific responsibilities may vary based on the size of the research site, the complexity of the study, and the sponsor’s requirements. Most often Clinical Research Coordinators reports to Principal Investigator (PI) and/or Clinical Research Manager
Job Summary
The Clinical Research Coordinator (CRC) plays a vital role in the conduct of clinical trials by providing essential administrative, operational, and clinical support. The CRC is responsible for coordinating and managing the daily activities of research studies, ensuring adherence to study protocols, Good Clinical Practice (GCP) guidelines, and relevant regulatory requirements. The CRC works closely with the Principal Investigator, study team members, sponsors, and other stakeholders to facilitate the successful and ethical conduct of clinical research.
Responsibilities
Study Coordination and Management
- Serve as the primary point of contact for assigned clinical trials.
- Coordinate all aspects of study initiation, conduct, and close-out activities.
- Develop and maintain study-related documents, including study binders, regulatory files, and subject files, ensuring they are complete and accurate.
- Track study progress, milestones, and timelines, and proactively identify and address potential issues.
- Schedule and coordinate study-related meetings, including site initiation visits, monitoring visits, and close-out visits.
- Manage and maintain investigational product (IP) accountability, including receipt, storage, dispensing, and return.
- Ensure adequate study supplies are available.
Participant Recruitment and Enrollment
- Assist in the development of recruitment strategies and materials.
- Screen potential participants for eligibility based on study inclusion and exclusion criteria.
- Obtain informed consent from eligible participants prior to their participation in the study.
- Maintain accurate and up-to-date enrollment logs.
Data Collection and Management
- Collect and accurately record study data in electronic data capture (EDC) systems or paper case report forms (CRFs).
- Ensure data quality, completeness, and integrity through regular review and source document verification.
- Address and resolve data queries in a timely manner.
- Maintain participant confidentiality and data security.
Protocol Adherence and Compliance
- Develop a thorough understanding of study protocols and related documents.
- Ensure that all study activities are conducted in accordance with the protocol, GCP guidelines, and relevant regulations.
- Identify and report protocol deviations and violations appropriately.
- Assist with internal and external audits and inspections.
Communication and Collaboration
- Communicate effectively with the Principal Investigator, study team members, sponsors, monitors, and other stakeholders.
- Serve as a liaison between the research site and the sponsor.
- Maintain positive and professional relationships with participants.
Regulatory Compliance
- Assist with the preparation and submission of Institutional Review Board (IRB)/Ethics Committee (EC) applications, amendments, and continuing review reports.
- Maintain and update regulatory binders and essential documents.
- Ensure compliance with all applicable local, national, and international regulations and guidelines.
Other Responsibilities
- Assist with budget development and management, as needed.
- Participate in training sessions and meetings as required.
- Perform other duties as assigned by the Principal Investigator or Clinical Research Manager.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline (e.g., biology, nursing, pharmacy, public health) or equivalent experience.
- Experience in clinical research is highly preferred.
- Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
- Strong organizational skills and attention to detail.
- Excellent communication, interpersonal, and problem-solving skills.
- Ability to work independently and as part of a team.
- Proficiency in computer applications, including word processing, spreadsheets, and database management.
- Certification as a Clinical Research Coordinator (e.g., ACRP or SOCRA) may be preferred or required.
Preferred Skills
- Experience with electronic data capture (EDC) systems.
- Familiarity with medical terminology.
- Experience in a specific therapeutic area.