Serve as the primary liaison between the site, study participants, investigators, and sponsors.
Coordinate and conduct study visits per protocol, ensuring accurate and timely data collection and documentation.
Obtain and document informed consent in compliance with ethical and regulatory standards.
Screen and enroll participants according to eligibility criteria; maintain recruitment logs.
Maintain accurate, complete, and up-to-date source documentation and electronic data capture (EDC).
Manage investigational products including receipt, storage, accountability, and administration oversight.
Monitor participants for adverse events and ensure timely reporting to all required parties.
Perform or coordinate study-related procedures such as vital signs, ECGs, blood draws, and lab sample processing/shipping.
Schedule subject visits and follow-up calls; manage calendars and visit reminders.
Assist with regulatory submissions, IRB documentation, and correspondence with sponsors and monitors.
Support patient retention and engagement efforts, including participation in recruitment events and community outreach.
Train or mentor new CRCs or ancillary staff as needed.
Maintain compliance with all SOPs, GCP guidelines, and applicable local/federal regulations. Requirements:
Background in Metabolic/Endocrine and Vaccine Studies preferred.
Bachelor s degree in a health, science, or related field preferred, but not required.
Alternatively, an associate degree with 3+ years of relevant CRC experience, or equivalent combination of education and experience.
3 6+ years of experience coordinating clinical trials required (more preferred).
Medical assistant, LPN, phlebotomy, or similar clinical background is a plus.
Strong understanding of ICH GCP, clinical trial phases, and FDA/IRB regulatory requirements.
Proficiency in data entry systems (e.g., EDC, CRIO) and Microsoft Office Suite.
Excellent organizational, time management, and communication skills.
Ability to manage multiple tasks and prioritize effectively under pressure.
High attention to detail and commitment to quality and compliance.
Ability to work independently and collaboratively within a cross-functional team.
Please reference Job number: 267613