Clinical Trials Coordinator - Impactful Research & Growth

Tekton Research; New Carlisle (OH); On-site; USD 42,000 - 58,000; Full time

Job summary

Tekton Research is seeking a detail-oriented Clinical Research Coordinator to manage daily trial activities and ensure protocol adherence. This role coordinates with investigators, sponsors, and regulatory bodies to maintain data integrity and participant safety.

Responsibilities include participant recruitment, specimen handling per protocol, regulatory documentation, and collaboration across multidisciplinary teams to ensure timely study execution and audits readiness.

Qualifications

• Bachelor’s degree in Nursing, Biology, Health Sciences, Public Health, or related field preferred.
• 6–12 months CRC experience or more.
• Working knowledge of 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 EDC systems and Microsoft Office applications.
• Excellent verbal and written communication skills.
• Ability to work independently while collaborating with multidisciplinary teams.

Responsibilities

• Coordinate and manage all aspects of assigned clinical trials from 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 promptly identify, document, and report adverse events.
• 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 and CTMS to maintain accurate study data.
• Ensure protocol compliance while maintaining participant care and research integrity.

Skills

GCP knowledge

Phlebotomy experience

Time management

Organizational skills

EDC systems

CTMS

Microsoft Office

Verbal and written communication

Independent work

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 detail-oriented Clinical Research Coordinator to manage daily trial activities and ensure protocol adherence. This role coordinates with investigators, sponsors, and regulatory bodies to maintain data integrity and participant safety.

Responsibilities include participant recruitment, specimen handling per protocol, regulatory documentation, and collaboration across multidisciplinary teams to ensure timely study execution and audits readiness.