Full-Time On-Site Clinical Trials Coordinator—Impact

ADP, Inc.

Longmont (CO)

On-site

USD 60,000 - 76,000

Full time

3 days ago
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Benefits offered by this job

Competitive compensation
Comprehensive benefits
Professional growth opportunities

Job summary

Tekton Research in Longmont, CO is seeking a Clinical Research Coordinator (CRC) to manage day-to-day trial operations on-site. The CRC will ensure adherence to study protocols, GCP, and regulatory requirements while serving as the liaison among investigators, sponsors, and participants.

The ideal candidate has a background in clinical research and experience with regulatory documentation, specimen processing, and EDC/CTMS systems.

Qualifications

  • Clinical research experience and understanding of GCP and regulatory requirements.
  • Experience with pediatric and adult phlebotomy and specimen processing.
  • Strong organizational and time management skills.

Responsibilities

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

Skills

GCP knowledge
FDA regulations
ICH guidelines
Regulatory processes
Verbal and written communication
Time management

Education

Bachelor's degree in Nursing, Biology, Health Sciences, Public Health, or related field
High school diploma or GED

Tools

EDC systems
CTMS
Microsoft Office

Job description

Tekton Research in Longmont, CO is seeking a Clinical Research Coordinator (CRC) to manage day-to-day trial operations on-site. The CRC will ensure adherence to study protocols, GCP, and regulatory requirements while serving as the liaison among investigators, sponsors, and participants.

The ideal candidate has a background in clinical research and experience with regulatory documentation, specimen processing, and EDC/CTMS systems.

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