Clinical Research Coordinator: Drive Trials & Impact

Tekton Research; New Carlisle (OH); On-site; USD 52,000 - 72,000; Full time

Job summary

Tekton Research is seeking a Clinical Research Coordinator (CRC) to manage day-to-day coordination of clinical trials, ensuring GCP regulatory compliance and data integrity across multiple studies.

Responsibilities include participant recruitment, enrollment, specimen handling, regulatory submissions, and collaboration with investigators, sponsors, and monitors in a fast-paced research environment.

Qualifications

• Bachelor’s degree preferred in a health sciences field; high school diploma acceptable with related experience.
• Minimum 6 months to 1 year of Clinical Research Coordinator experience.
• Working knowledge of GCP, FDA regulations, ICH guidelines, and clinical research processes.
• Experience with pediatric and adult phlebotomy and specimen processing.
• Excellent verbal and written communication skills.

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.
• Collect, process, package, and ship laboratory specimens according to protocol and sponsor requirements.
• Maintain source documentation, regulatory binders, and study records in compliance with GCP, FDA regulations, and policies.
• Monitor participant safety and report adverse events promptly.
• Prepare and submit regulatory documents, including IRB submissions 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 participant care and research integrity.

Skills

Communication skills

Organizational skills

Independence & teamwork

Phlebotomy

Education

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

Tools

EDC systems

CTMS

Microsoft Office

Job description

Tekton Research is seeking a Clinical Research Coordinator (CRC) to manage day-to-day coordination of clinical trials, ensuring GCP regulatory compliance and data integrity across multiple studies.

Responsibilities include participant recruitment, enrollment, specimen handling, regulatory submissions, and collaboration with investigators, sponsors, and monitors in a fast-paced research environment.