Job Summary
We are seeking a dedicated Research Assistant specializing in Clinical Research to support ongoing clinical trials. The ideal candidate will assist with data collection, management, and analysis, ensuring the integrity and accuracy of research data. This role offers an excellent opportunity for individuals interested in advancing medical research and gaining hands-on experience in a clinical setting.
Key Responsibilities
- Collaborate with the Principal Investigator (PI), Sub-Investigators, physicians, nurses, and multidisciplinary research team to identify, recruit, screen, and enroll eligible participants for clinical trials.
- Conduct the informed consent process and perform protocol-specific screening assessments, medical history review, and collection of study questionnaires and patient-reported outcomes.
- Coordinate and execute all study visits in accordance with study protocols, ICH-GCP guidelines, sponsor requirements, and institutional policies.
- Perform protocol-required clinical assessments, collect vital signs, review concomitant medications, document adverse events, and ensure participant safety throughout the study.
- Collect, process, prepare, store, and ship biological specimens (blood, urine, stool, biopsy specimens, and other samples) according to protocol and laboratory manuals while maintaining sample integrity.
- Coordinate study-related procedures including endoscopy/colonoscopy, imaging, laboratory testing, infusion appointments, and follow-up visits with investigators, clinical staff, pharmacies, and external vendors.
- Maintain accurate source documentation and enter study data into electronic data capture (EDC) systems in compliance with ICH-GCP, ALCOA+ principles, and study timelines.
- Identify protocol deviations, safety concerns, or data discrepancies, communicate findings to the PI and study team, and assist with implementing corrective actions.
- Maintain regulatory documentation including Investigator Site Files (ISF/eISF), ethics submissions, protocol amendments, essential documents, delegation logs, training records, and sponsor correspondence.
- Coordinate study logistics including investigational product accountability, laboratory kits, study supplies, participant reimbursement, and monitoring visit preparation.
- Review study protocols, investigator brochures, laboratory manuals, SOPs, and other study-related documentation to ensure protocol compliance.
- Participate in sponsor monitoring visits, audits, and regulatory inspections by preparing and maintaining study documentation.
- Participate in research team meetings, provide study status updates, assist with recruitment strategies, and contribute to continuous quality improvement initiatives.
Qualifications
- Bachelor's degree in Health Sciences, Life Sciences, Nursing, or a related healthcare field. Or Clinical Research Certificate (or equivalent clinical research training) is considered an asset.
- Previous clinical research experience preferred.
- Previous experience in Gastroenterology (GI) or Inflammatory Bowel Disease (IBD) clinical trials is a strong asset.
- Working knowledge of ICH-GCP, Health Canada regulations, and clinical research best practices.
- Experience with electronic data capture (EDC), electronic medical records (EMR), and Microsoft Office applications is preferred.
- Strong organizational, communication, and interpersonal skills with the ability to manage multiple studies simultaneously in a fast-paced environment.
Pay: $22.00-$26.00 per hour
Benefits:
Work Location: In person
