Clinical Research Associate
Company: Medical University of South Carolina
- Location: Canada
- Seniority: Entry level
- Employment type: Contract
- Posted: Yesterday
- Offer language: English
Job description
The Data Coordination Unit (DCU) is an academic clinical research organization located at the Medical University of South Carolina. We are currently looking for a site monitor located in Canada that is fluent in French. This will be an independent contract position on an as needed basis with a competitive hourly rate. To be considered for the position, include your physical address on your resume. Preference is for monitors who reside near airport hubs.
The selected candidates will work closely with DCU’s study team and Project Manager to ensure that the rights and well-being of human subjects are protected; trial data are accurate, complete, and verifiable from source documents; and the trial is conducted in compliance with the currently approved protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.
Key Responsibilities:
- Conduct on-site and/or remote monitoring visits as outlined in project-specific monitoring plans.
- Ensure investigator/staff compliance with federal regulations, GCP, and study protocol.
- Perform on-site/remote source document verification and generate queries for discrepant data.
- Verify the receipt, handling, accounting, storage conditions, and availability of investigational product and other study materials.
- Ensure site reporting of adverse events and unanticipated events involving risk.
- Address any additional critical issues identified and requested by the DCU.
- Write and submit monitor visit reports within the required timeframe.
- Follow up and close action items and queries.
- Schedule monitor visits, arrange travel, and submit invoices for reimbursement according to the DCU’s travel and reimbursement guidelines.
Professional skills & experience:
- Bachelor’s degree in life sciences.
- Minimum of 4 years of site monitoring experience, preferably in neurology, cardiology, digestive diseases or emergency medicine. Must have experience in clinical trials conducted in the hospital setting.
- Comprehensive and practical knowledge of the principles of clinical trial conduct in accordance with /GCP, federal regulations, and other clinical trials-related guidelines.
- Thorough knowledge of clinical development processes and the conduct of clinical studies.
- Professional proficiency in both spoken and written English and French.
- Experience with CTMS and medical record systems.
Personal skills & abilities
- Excellent communication skills.
- Strong organizational and time management skills.
- Quality oriented with attention to details.
- Highly proactive, self-motivated, professional and dedicated.
- Excellent computer skills.
- Ability to follow project-specific monitoring plans and DCU’s monitoring and Travel and Reimbursement policies.
