Dynamic Clinical Research Coordinator | Study Start-to-Close

Tekton Research Inc; Longmont (CO); Presencial; USD 55.000 - 75.000; Jornada completa

Descripción de la vacante

Tekton Research Inc. is hiring a Clinical Research Coordinator to manage day-to-day coordination of clinical trials in Longmont, CO. The role requires strong organization, compliance with GCP and FDA regulations, and experience with lab specimen handling.

The CRC will serve as a liaison among investigators, sponsors, study participants, and regulators, ensuring participant safety and data integrity in a fast-paced setting. On-site, full-time position with growth opportunities.

Formación

• Bachelor’s degree in a related field preferred.
• 6 months to 1 year of CRC experience.
• Working knowledge of GCP, FDA regulations, ICH guidelines.
• 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 Microsoft Office applications.
• Excellent verbal and written communication skills.
• Ability to work independently while collaborating with multidisciplinary teams.

Responsabilidades

• 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 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.

Conocimientos

GCP knowledge

FDA regulations

EDC systems

MS Office

Communication skills

Time management

Independent work

Team collaboration

Educación

Bachelor’s degree in Nursing

Bachelor’s degree in Biology

Bachelor’s degree in Public Health

Herramientas

EDC systems

CTMS

MS Office

Descripción del empleo

Tekton Research Inc. is hiring a Clinical Research Coordinator to manage day-to-day coordination of clinical trials in Longmont, CO. The role requires strong organization, compliance with GCP and FDA regulations, and experience with lab specimen handling.

The CRC will serve as a liaison among investigators, sponsors, study participants, and regulators, ensuring participant safety and data integrity in a fast-paced setting. On-site, full-time position with growth opportunities.