Clinical Research Coordinator

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 a growth-oriented clinical research organization committed to conducting high-quality clinical trials that advance medical knowledge and improve patient care. We are a collaborative, values-driven team that believes in Focus, Discipline, and Accountability. At Tekton Research, we take pride in doing excellent work while fulfilling our mission of Making Life Better.

We offer competitive compensation, comprehensive benefits, and opportunities for professional growth in a supportive and fast-paced research environment.

Position Summary:

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.

Key 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 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.

Required Qualifications:

• High school diploma or GED required; Bachelor's degree in Nursing, Biology, Health Sciences, Public Health, or a related field preferred.
• Minimum of six months to one (1) year of Clinical Research Coordinator experience.
• Working knowledge of Good Clinical Practice (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 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.

Preferred Qualifications:

• Current ACRP-CRC or SOCRA certification.
• 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.

Why Join Tekton Research?

At Tekton Research, you'll join a team dedicated to excellence, innovation, and improving lives through clinical research. We foster a collaborative culture where professional development is encouraged, contributions are valued, and every team member plays an important role in advancing healthcare.