Job Summary:
We are seeking a detail-oriented and dedicated Clinical Research Coordinator to join our research team. This individual will be responsible for coordinating, implementing, and monitoring clinical trials to ensure compliance with regulatory standards, protocol requirements, and timelines. The Clinical Research Coordinator will work closely with research participants, physicians, and other healthcare staff to ensure the success of clinical studies and trials.
Key Responsibilities:
Study Management and Coordination:
- Assist in planning and coordinating clinical trials from start-up to close-out.
- Recruit, screen, and enroll study participants according to the protocol criteria.
- Schedule and conduct study visits, including patient assessments, specimen collection, and data gathering.
- Ensure informed consent is properly obtained and documented for all participants.
Data Collection and Documentation:
- Accurately collect, record, and maintain data in case report forms (CRFs) or electronic databases.
- Monitor participants' adherence to study protocols and follow-up schedules.
- Maintain accurate and organized documentation, including medical records, source documents, and study logs.
Regulatory Compliance:
- Adhere to all institutional, federal, and international guidelines for conducting clinical trials (such as GCP and FDA regulations).
- Prepare and submit necessary documentation to Institutional Review Boards (IRBs) and regulatory authorities.
- Maintain regulatory documents, including IRB correspondence, informed consent forms, and study protocols.
Patient Interaction and Support:
- Educate participants about the study, its purpose, procedures, risks, and potential benefits.
- Serve as the primary point of contact for participants, addressing their questions and concerns.
- Monitor participants' well-being and report any adverse events or protocol deviations.
Collaboration and Communication:
- Coordinate with the Principal Investigator and research team to ensure protocol adherence.
- Attend team meetings, sponsor meetings, and monitoring visits as required.
- Maintain effective communication with sponsors, CROs, and other stakeholders.