Clinical Research Coordinator

Key Responsibilities

• Career Summary
• Recruit, screen, consent, and schedule study participants according to protocol requirements.
• Perform pediatric and adult phlebotomy, including blood collection for pediatric participants from newborn through 17 years of age, using age-appropriate techniques while ensuring patient comfort and safety.
• 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.
• Absorb and prepare for 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

• High school diploma or GED required; Bachelor's degree in Nursing, Biology, Health Sciences, Public Health, or a related field preferred.
• Minimum of one (1) year of Clinical Research Coordinator experience.
• Working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and clinical research processes.
• Required experience performing pediatric phlebotomy on patients from birth through 17 years of age, including infants, children, and adolescents.
• Candidates must demonstrate proficiency in obtaining blood specimens safely while delivering compassionate, age-appropriate care.
• 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.
• Ability to work independently while collaborating effectively with multidisciplinary teams.