Job Summary:

CDS is looking for a local (Winnipeg Based) Clinical Research Associate (CRA) to perform the clinical monitoring aspects for specific projects on a contract basis.

The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs.

Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing selection, initiation, periodic monitoring and close-out of investigational sites in accordance with ICH GCP guidelines.

Duties and Responsibilities:

- May conduct pre-study site assessment/qualification visits, collection and review essential documents, prepare evaluative reports; participate in the final selection of investigators and study sites and participate in study start-up activities.
- May conduct site initiation visits; advise and train site personnel on sponsor and regulatory requirements for study; participate in site meetings and multi-centre investigator meetings and prepare visit reports.
- Site Management Activities, including maintain all essential clinical documents and manage supply of investigational product throughout the trials
- Conduct site monitoring visits and follow-up on any outstanding issues; ensure all clinical aspects of the studies are being carried out in accordance with the clinical protocol, ICH GCP, state/provincial and federal/country regulations, guidelines and policies; and prepare site status reports and monitoring visit reports.
- Review site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies and discrepancies; and provide remedial training and/or initiate corrective action as required.




- May conduct investigator site close-out visits and assist in the termination of clinical studies by identifying items and issues for review and/or follow-up; collection of necessary documents, reconciliation of study drug/device and disposition, review of completeness and accuracy of files, retrieval of relevant codes, prepare study close-out / termination reports.
- Assist in the reconciliation of and follow up on adverse event reporting, and responsible adverse event reporting to ensure appropriate notification and compliance with regulatory agency, IRB/REB and SOPs
- May assist sites with preparation for regulatory agency, sponsor, or IRB/REB audits.
- Current projects are local (Winnipeg). Future projects may involve travel within Canada & USA up to 60%.
- May perform other miscellaneous job-related duties as assigned.

Interacts with (where applicable):

- Sponsor personnel. This may include Lead CRA, Project Management, Documentation Personnel, Trial Assistants, Data Management & Clinical Safety.
- Internal Quality Assurance.
- Associated or trial related Contract Research Organizations (CROs).
- Internal Lead CRA, Project Management, Documentation Personnel, Trial Assistants, & Clinical Safety.
- Investigational Site Personnel (Principal Investigator, Research Coordinator, etc.).
- Clinical Team (other monitors, etc).

Competencies:

- Must possess excellent written and verbal communication skills and have the ability to develop and deliver both oral and written presentations.
- Ability to make evaluative judgments.
- Ability to provide advice,



guidance, and support to professional staff in area of specialty
- Ability to develop and implement clinical research monitoring plans and standard operating procedures.
- Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment.

Qualifications:

- Bachelor's degree in life sciences or related field or certification in a related allied health profession from an appropriately accredited institution (i.e. BN, RN, MT, PA, RPh, RT) GCP Certification, or certification with SoCRA or ACRP preferred.
- A minimum of 2 years experience in clinical research or related research field preferred.
- Knowledge of all regulations and guidelines pertaining to the conduct of clinical trials on human subjects (i.e. ICH GCP, FDA and Health Canada regulations).
- Knowledge of randomized controlled clinical trials principles, methodology, and procedures.
- Knowledge of current and developing trends and standards in clinical trials monitoring.
- Computer/Laptop usage skills (knowledge of Microsoft Office, including Word, PowerPoint, Excel and Outlook).

Accountability:

- Ensures compliance with all regulatory and contractual requirements by quality controlling the execution of clinical protocol and data management for a clinical trial(s) at multiple sites.
- Ensures validity of studies by establishing and maintaining sound clinical and data collection practices.
- Ensures compliance with established protocols, regulatory and contractual requirements; appropriate research methodology; and study timelines by monitoring the conduct and progress of the studies.
- Ensures appropriate transmission of clinical case data to the data management centre(s); reviews case report queries and problems, and assists in data review and correction as appropriate.

📌 Clinical Research Associate (Winnipeg)
🏢 Clinical Development Solutions
📍 Winnipeg