Position Summary:
We are seeking a motivated and detail-oriented Clinical Research Coordinator (CRC) to manage and coordinate clinical research studies in accordance with Good Clinical Practice (GCP), institutional guidelines, and federal regulations. The CRC will work closely with investigators, sponsors, and participants to ensure the integrity of study protocols and data collection.
Key Responsibilities:
- Coordinate and conduct all aspects of clinical research studies, including participant recruitment, consent, scheduling, and follow-up.
- Ensure compliance with study protocols and regulatory requirements (Health Canada, IRB, ICH-GCP).
- Collect and enter data accurately into electronic data capture (EDC) systems.
- Maintain study documents, including electronic regulatory binders, subject files, and case report forms.
- Monitor and report adverse events and ensure timely communication with the IRB and sponsors.
- Prepare for and participate in monitoring visits, audits, and inspections.
- Collaborate with cross-functional teams, including principal investigators, sponsors, and other research personnel.
Qualifications:
- Bachelor’s degree in health sciences, life sciences, nursing, or a related field (required).
- Minimum [1-3] years of experience in clinical research (preferred).
- Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) a plus.
- Phlebotomy certification and proficiency in drawing with ability to process and ship per IATA requirements.
- Strong knowledge of GCP, Health Canada, and IRB regulations.
- Excellent organizational, communication, and problem-solving skills.
- Proficiency with EDC systems (e.g., Medidata, or RAVE) and Microsoft Office Suite.
Work Environment:
- On-site in physician practice and clinical research setting.
- May require handling of biological samples and/or working with patients.
