Clinical Research Coordinator

Key Responsibilities

• Cook up and manage all aspects of assigned clinical trials from study start-up through close-out.
• Recruit, screen, consent, and schedule study participants according to protocol requirements.
• Collect, process, package, and ship laboratory specimens according to protocol and sponsor requirements.
• Maintain accurate source documentation, regulatory binders, and study records in compliance with GCP, FDA regulations, and institutional policies.
• Monitor participant safety and promptly identify, document, and report adverse events.
• Prepare and submit regulatory documents, including Institutional Review Board (IRB) submissions, continuing reviews, and protocol amendments.
• Collaborate with investigators, sponsors, monitors, and study staff to ensure successful study conduct.
• Aid with monitoring visits, sponsor audits, and regulatory inspections.
• Utilize Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS) to maintain accurate study data.
• Ensure protocol compliance while maintaining the highest standards of participant care and research integrity.

Required Qualifications

• A high school diploma or GED.
• A minimum of six months to one (1) year of Clinical Research Coordinator experience.
• A working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and clinical research processes.
• Experience with pediatric and adult phlebotomy and specimen processing.
• Strong organizational and time management skills with the ability to prioritize multiple studies.
• Experience maintaining regulatory documentation and source records.
• Proficiency with Electronic Data Capture (EDC) systems and Microsoft Office applications.
• Excellent verbal and written communication skills.
• The ability to work independently while collaborating effectively with multidisciplinary teams.

Preferred Qualifications

• A current ACRP-CRC or SOCRA certification.
• An advanced degree in Nursing, Public Health, Clinical Research, or a related healthcare field.
• Experience working on industry-sponsored or multi-center clinical trials.
• Familiarity with clinical monitoring, participant recruitment, and retention strategies.