Clinical Research Coordinator

ClinSurge Research; Ottawa; On-site; CAD 55,000 - 75,000; Full time

Job summary

ClinSurge Research in Ottawa, Ontario seeks a motivated Clinical Research Coordinator to manage studies in line with GCP, Health Canada and IRB rules, ensuring data integrity and protocol compliance.

You will recruit and consent participants, schedule visits, enter data in EDC systems (Medidata or RAVE), maintain regulatory binders, report adverse events, and assist during monitoring visits; a health sciences bachelor’s degree and 1–3 years’ experience are preferred.

Qualifications

• Bachelor's degree in health sciences, life sciences, nursing, or a related field.
• 1–3 years of clinical research experience preferred.
• CCRC or CCRP credentials are a plus.
• Phlebotomy certification and proficiency in IATA shipping.
• Strong knowledge of GCP, Health Canada, IRB regulations.
• Proficiency with EDC systems (Medidata, RAVE) and MS Office.
• On-site work in physician practice and clinical research setting.
• May handle biological samples or work with patients.

Responsibilities

• Coordinate and conduct 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.

Skills

GCP knowledge

Regulatory compliance

Data entry

Communication

Organization

Problem solving

On-site coordination

Education

Bachelor's degree in health sciences, life sciences, nursing, or related field

Tools

Medidata

RAVE

Microsoft Office Suite

Job description

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.
• On-site in physician practice and clinical research setting.
• May require handling of biological samples and/or working with patients.