Dynamic Temporary Clinical Research Coordinator (On-Site)

Tekton Research; Longmont (CO); On-site; USD 55,000 - 75,000; Full time

Job summary

Tekton Research seeks a Clinical Research Coordinator (CRC) for an on-site temporary role. You will manage daily trial operations, ensure protocol and regulatory compliance, and serve as a liaison among investigators, sponsors, participants, and regulators.

Ideal candidates have knowledge of GCP/FDA guidelines, experience with EDC/CTMS systems, and strong organizational skills for handling multiple studies in a fast-paced environment at Tekton Research.

Qualifications

• Minimum education as listed; degree preferred in health-related field.
• Working knowledge of GCP, FDA regulations, ICH guidelines.
• Experience with EDC and CTMS systems; strong regulatory documentation skills.
• Excellent communication and time-management abilities.

Responsibilities

• Coordinate and manage all aspects of assigned clinical trials from start-up through close-out.
• Recruit, screen, consent, and schedule participants per protocol.
• Collect, process, and ship laboratory specimens per protocol and sponsor requirements.
• Maintain source documentation and trial records in compliance with GCP and FDA.
• Monitor participant safety; document and report adverse events promptly.
• Prepare regulatory submissions, IRB docs, and protocol amendments.
• Collaborate with investigators, sponsors, monitors, and study staff.
• Assist with monitoring visits and sponsor audits.
• Utilize EDC and CTMS to maintain accurate data.
• Ensure protocol compliance and research integrity.

Skills

GCP knowledge

FDA regulations

ICH guidelines

EDC systems

CTMS

Phlebotomy (pediatric & adult)

Regulatory documentation

Communication skills

Time management

Education

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

Tools

EDC systems

CTMS

Microsoft Office

Job description

Tekton Research seeks a Clinical Research Coordinator (CRC) for an on-site temporary role. You will manage daily trial operations, ensure protocol and regulatory compliance, and serve as a liaison among investigators, sponsors, participants, and regulators.

Ideal candidates have knowledge of GCP/FDA guidelines, experience with EDC/CTMS systems, and strong organizational skills for handling multiple studies in a fast-paced environment at Tekton Research.