Clinical Research Coordinator: Impactful Trials & Growth

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

Job summary

Tekton Research is seeking a Clinical Research Coordinator (CRC) to oversee day-to-day coordination and management of clinical studies in a fast-paced environment. You will ensure adherence to study protocols, GCP, and regulatory requirements, while safeguarding participant safety and data integrity.

The CRC will recruit and screen participants, manage regulatory documents, and support IRB submissions, monitoring visits, and audits, utilizing EDC and CTMS systems to maintain accurate records.

Qualifications

• High school diploma or GED; Bachelor's degree in Nursing, Biology, Health Sciences, or Public Health preferred.
• 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.
• 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 effectively 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 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 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 EDC systems and CTMS to maintain accurate study data.
• Ensure protocol compliance while maintaining the highest standards of participant care and research integrity.

Skills

Organizational skills

Time management

Communication skills

Attention to detail

Education

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

High school diploma or GED

Advanced degree (optional)

Tools

EDC systems

Microsoft Office

Job description

Tekton Research is seeking a Clinical Research Coordinator (CRC) to oversee day-to-day coordination and management of clinical studies in a fast-paced environment. You will ensure adherence to study protocols, GCP, and regulatory requirements, while safeguarding participant safety and data integrity.

The CRC will recruit and screen participants, manage regulatory documents, and support IRB submissions, monitoring visits, and audits, utilizing EDC and CTMS systems to maintain accurate records.