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About the Role
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.
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.
Requirements
- High school diploma or GED required.
- 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.
Skills
- Phlebotomy
- Specimen processing
- Organizational skills
- Time management
- Regulatory documentation
- Source records maintenance
- Electronic Data Capture (EDC) systems
- Microsoft Office applications
- Verbal communication
- Written communication
Location
- On-Site
Work Type
- Temporary
- Full-time
Experience Level
- 6 months to 1 year experience
Education Level
- High school diploma or GED
- Bachelor's degree in Nursing, Biology, Health Sciences, Public Health, or a related field preferred.
- Advanced degree in Nursing, Public Health, Clinical Research, or a related healthcare field.
Benefits
- Competitive compensation
- Comprehensive benefits
- Opportunities for professional growth
About the Company
- 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 foster a collaborative culture where professional development is encouraged, contributions are valued, and every team member plays an important role in advancing healthcare.