Clinical Research Coordinator II

This Role Makes a Difference

The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.

How You'll Make An Impact

• Coordination and Conduct of Clinical Trials
  • Study Planning and Scheduling:
    • Prioritizing tasks according to study protocol timelines.
    • Managing scheduling conflicts between visits and procedures through close collaboration with Investigators, nurses, and the PSC.
  • Regulatory Compliance:
    • Adhering to FDA and ICH GCP guidelines in clinical trial conduct.
    • Ensuring all study procedures are performed in accordance with Good Clinical Practice (GCP) standards.
    • Maintaining knowledge of and compliance with internal Care Access SOPs in daily activities.
  • Collaboration with the Study Team and Participants:
    • Professional communication with the Principal Investigator (PI), study staff, and Sponsor/CRO representatives.
    • Close cooperation with investigators and the study team, supporting investigators and nurses during patient visits, and ensuring patient documentation is prepared prior to visits.
    • Maintaining participant relationships in alignment with protocol and ethical requirements.
    • Training participants on study materials (e.g., paper or electronic diaries), supporting device usage, verifying entries, issuing and collecting diaries, etc.
  • Monitoring Quality and Safety:
    • Tracking quality metrics and visit outcomes.
    • Supporting investigators in identifying and reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) in line with protocol and procedures.
    • Preventing protocol deviations and promptly resolving issues in documentation and study processes.
    • Participating in selection, initiation, monitoring, and close-out visits; collaborating with monitors, analyzing findings from post-visit letters, implementing corrective actions, and confirming completion of all prior visit issues.
    • Preparing the site for audits and inspections and participating in these activities.
    • Controlling versions of key study documents (Investigator’s Brochure, protocol, manuals).