Clinical Research Coordinator

Summary

The Clinical Research Coordinator I (CRC) supports the conduct of clinical trials by coordinating study visits, managing data collection, and ensuring compliance with protocols and regulatory guidelines. This role involves direct interaction with participants including monitoring the health of each participant throughout the trial. The CRC plays a key part in maintaining study integrity and quality and collaborating with the Principal Investigator (PI) to provide oversight of the study to ensure adherence to Good Clinical Practice (GCP) guidelines.

• Communicate clearly and professionally with study participants regarding study objectives and ongoing instructions.
• Adhere to site standard operating procedures (SOPs).
• Administer questionnaires and monitor participant compliance with study protocols.
• Respond to participant needs promptly and appropriately.
• Collect and document patient medical history and health conditions.
• Obtain and document informed consent from study participants.
• Maintain accurate records of investigational product (IP) dispensation and accountability.
• Coordinate with laboratories to ensure timely testing and reporting.
• Collect and document information on concomitant medications.
• Review medical records for protocol compliance.
• Perform and document assessments for adverse events (AEs) and serious adverse events (SAEs).
• Conduct clinical procedures including EKGs, vital signs, nasal swabs, and other protocol-specific tasks.
• Review clinical laboratory reports in accordance with protocol requirements.
• Maintain up-to-date regulatory files for the research site.
• Verify the accuracy and completeness of collected data.
• Monitor and document temperatures for IP storage.
• Support recruitment and engagement of study participants as needed.
• Develop electronic source (eSource) documents in accordance with study protocols.
• Manage study startup documentation, training, and timelines for assigned protocols.
• Ensure all protocol requirements and deadlines are met consistently.
• Maintain strict confidentiality and compliance with regulatory standards.
• Assist with preparation for monitoring visits.
• Enter data into electronic data capture (EDC) systems and resolve data queries.
• Perform other duties as assigned.

The Clinical Research Coordinator I (CRC) supports the conduct of clinical trials by coordinating study visits, managing data collection, and ensuring compliance with protocols and regulatory guidelines. This role involves direct interaction with participants including monitoring the health of each participant throughout the trial. The CRC plays a key part in maintaining study integrity and quality and collaborating with the Principal Investigator (PI) to provide oversight of the study to ensure adherence to Good Clinical Practice (GCP) guidelines.

• Communicate clearly and professionally with study participants regarding study objectives and ongoing instructions.
• Adhere to site standard operating procedures (SOPs).
• Administer questionnaires and monitor participant compliance with study protocols.
• Respond to participant needs promptly and appropriately.
• Collect and document patient medical history and health conditions.
• Obtain and document informed consent from study participants.
• Maintain accurate records of investigational product (IP) dispensation and accountability.
• Coordinate with laboratories to ensure timely testing and reporting.
• Collect and document information on concomitant medications.
• Review medical records for protocol compliance.
• Perform and document assessments for adverse events (AEs) and serious adverse events (SAEs).
• Conduct clinical procedures including EKGs, vital signs, nasal swabs, and other protocol-specific tasks.
• Review clinical laboratory…