Clinical Research Coordinator — Shape Impactful Trials

ADP, Inc.; New Carlisle (OH); On-site; USD 45,000 - 65,000; Full time

Job summary

Tekton Research in New Carlisle, OH is seeking a Clinical Research Coordinator to oversee day-to-day coordination of clinical trials, ensuring GCP compliance and participant safety. The CRC acts as the primary liaison among investigators, sponsors, participants, and regulatory bodies, managing data integrity and study execution.

The ideal candidate has a high school diploma or GED, 6–12 months of CRC experience, knowledge of GCP/FDA guidelines, and strong organizational and communication skills.

Qualifications

• High school diploma or GED required; Bachelor's degree preferred.
• 6–12 months CRC experience.
• Working knowledge of GCP and FDA regulations.
• Experience with pediatric and adult phlebotomy and specimen processing.
• Strong organizational and time management skills.
• Experience maintaining regulatory documentation and source records.
• Proficiency with EDC systems and MS Office.
• Excellent verbal and written communication skills.
• Ability to work independently with multidisciplinary teams.

Responsibilities

• Coordinate all aspects of assigned clinical trials from study start-up through close-out.
• Recruit, screen, consent, and schedule study participants per protocol.
• Collect, process, package, and ship laboratory specimens per protocol.
• Maintain source documentation, regulatory binders, and study records per GCP and FDA regulations.
• Monitor participant safety and promptly identify, document, and report adverse events.
• Prepare and submit IRB submissions, continuing reviews, and protocol amendments.
• Collaborate with investigators, sponsors, monitors, and study staff for successful conduct.
• Assist with monitoring visits, sponsor audits, and regulatory inspections.
• Utilize EDC and CTMS to maintain accurate study data.

Skills

Time management

Communication

Independent work

Multidisciplinary teamwork

Education

High school diploma or GED

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

Tools

EDC systems

CTMS

Microsoft Office

Job description

Tekton Research in New Carlisle, OH is seeking a Clinical Research Coordinator to oversee day-to-day coordination of clinical trials, ensuring GCP compliance and participant safety. The CRC acts as the primary liaison among investigators, sponsors, participants, and regulatory bodies, managing data integrity and study execution.

The ideal candidate has a high school diploma or GED, 6–12 months of CRC experience, knowledge of GCP/FDA guidelines, and strong organizational and communication skills.