- BSc in Sciences or Healthcare related discipline
- Experience in working as a clinical trial monitor
- Ability for US travel
Clinical Research AssociateToronto, ON, Canada
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CLINICAL RESEARCH ASSOCIATE
Act as liaison between site personnel and the sponsor. Monitor the conduct of clinical trials and ensure compliance with protocols, regulatory requirements, good clinical practices and established timelines.
Task No. 1
Assist in the development and writing of clinical trial monitoring plans and site training materials.
Task No. 2
Conduct site qualification visits for clinical studies to assess feasibility in the center and interest of the investigator. Complete qualification visit reports.
Task No. 3
Conduct site initiation visits for clinical studies. Ensure site personnel (including investigators, coordinators, pharmacists) are properly trained on the protocol and relevant trial materials and complete initiation visit reports.
Task No. 4
Adhere to monitoring plans, eg. monitoring visit type, frequency, and required critical monitoring activities; and meet expected timelines for completion of monitoring activities and submission of written monitoring reports.
Task No. 5
Monitor clinical trial progress through a combination of data review and on-site monitoring visits. Verify compliance with patient-consent process, serious adverse events reporting process and ensure that overall trial data is consistent with patient clinical notes and other source documentation (source data verification).
Task No. 6
Ensure Investigator and study team is in compliance with protocols, regulatory requirements, and applicable ICH/GCP guidelines.
Task No. 7
Verify the receipt, handling, accounting, storage conditions and availability of investigational product and other trial supplies. Liaise with internal QA and site staff where necessary to replenish site’s inventory.
Task No. 8
Provide recommendations and guidance to site personnel to avoid redundant errors and deviations, and assist in audit readiness and preparation.
Task No. 9
Conduct site close out visits for clinical studies. Ensure the completion, collection and appropriate retention of all regulatory and study documents and complete closure reports.
Bachelor of health sciences, nursing, biomedical sciences, pharmacy, pharmacology, or related discipline.
CCRP Certification is an asset.
Thorough knowledge of ICH guidelines and GCP including basic understanding of regulatory requirements.
Thorough knowledge of monitoring procedures and the clinical trial process.
Proficient in the use of Microsoft Office and specialized software for electronic databases and e-CRFs.
Availability to travel frequently within North America.EXPERIENCE
3+ years of relevant clinical research experience or 2+ years of monitoring experience
Bachelor’s degree in a related health profession or a field related to research compliance
Therapeutic area experience is preferred: critical care/sepsis, in hospital trials
Category: Biotechnology & Pharmaceutical
Reference ID: CA7677BM001342
Date Posted: 13/03/2019