Pediatric Clinical Research Coordinator & Phlebotomy

Tekton Research; Richmond (VA); On-site; USD 55,000 - 85,000; Full time

Job summary

Tekton Research is seeking a Clinical Research Coordinator with pediatric phlebotomy experience to oversee day-to-day management of trials on-site. You will liaise with investigators, sponsors, and regulatory bodies, ensuring patient safety, data integrity, and successful study execution.

The role requires a minimum of one year in CRC, GCP/FDA knowledge, and strong organizational skills. You will perform pediatric and adult phlebotomy and utilize EDC/CTMS systems to maintain clinical data, in a

Qualifications

• Minimum of one year of Clinical Research Coordinator experience.
• Experience performing pediatric phlebotomy from birth through 17 years of age.
• Working knowledge of GCP, FDA regulations, ICH guidelines, and clinical research processes.
• Strong organizational and communication skills; ability to work independently.

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.
• 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 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 EDC systems and CTMS to maintain accurate study data.
• Ensure protocol compliance while maintaining high standards of participant care and research integrity.

Skills

GCP knowledge

FDA regulations

EDC systems

CTMS

Microsoft Office

Education

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

Tools

EDC systems

CTMS

Microsoft Office

Job description

Tekton Research is seeking a Clinical Research Coordinator with pediatric phlebotomy experience to oversee day-to-day management of trials on-site. You will liaise with investigators, sponsors, and regulatory bodies, ensuring patient safety, data integrity, and successful study execution.

The role requires a minimum of one year in CRC, GCP/FDA knowledge, and strong organizational skills. You will perform pediatric and adult phlebotomy and utilize EDC/CTMS systems to maintain clinical data, in a