Clinical Research Coordinator

Tekton Research Inc•Richmond, VA

4d•Onsite

About The Position

The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and management of clinical research studies, ensuring compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. The CRC serves as the primary liaison between investigators, sponsors, study participants, and regulatory agencies while ensuring participant safety, data integrity, and successful study execution. This role requires excellent organizational skills, strong attention to detail, and the ability to manage multiple clinical trials simultaneously in a dynamic environment.

Requirements

High school diploma or GED required
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.

Nice To Haves

Bachelor's degree in Nursing, Biology, Health Sciences, Public Health, or a related field preferred.
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.

Responsibilities

Coordinate 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.
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.
Assist 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.