Clinical Research Associate (CRA)

Job description

Job Description

MULTIPLE POSITIONS IN MAJOR CITIES ACROSS CANADA

Central point of contact between Novartis and the Investigational site personnel to ensure that clinical trials are conducted in Canada according to Novartis SOPs, Health Authority regulations and Good Clinical Practice, and that agreed targets (eg. number of patients, key milestones) are met.

Major Accountabilities
• Assist in identifying potential investigators for clinical trials;
• Conduct site selection visit and appropriately assess adequacy of site personnel and facilities to conduct clinical trials;
• Conduct site initiation visits and train site personnel on study conduct, use of trial related tools (e.g. Case Report Form (CRF) completion) and adherence to Good Clinical Practice (GCP);
• Ensure patient recruitment strategies are in place and work with investigational sites to meet recruitment goals;
• Conduct regular monitoring visits as per Monitoring Plan to ensure patient safety, data integrity and compliance with protocol, GCP and local regulations. Address issues and follow them until completion / escalate issues if necessary;
• Ensure proper management, accountability and tracking of Clinical Trial Drug Supplies;
• Conduct Close-out visit and inform investigators of responsibilities; provides feedback on site performance for future trials;
• Assist data management in resolving issues & queries locally during database lock;
• Continuously improve skills by timely completion of assigned global and local training;
• As part of development opportunities, may be given additional tasks and/or may be asked to act as a lead CRA in Canada for a given trial.
• COMPULSORY: Associate shall be accountable to perform all duties listed in Role Profile in accordance with applicable GxP principles, and internal/external regulations (e.g. Novartis Code of Conduct, Novartis Pharma Principles and Practices for Professionals (NP4), Rx&D Code of Ethical Practices, Health Canada and all other relevant regulations).

Desired profile

• Minimal requirement B.Sc. or B. Nursing
• Minimum of 2 years' experience in clinical research
• Collaboration/Interpersonal skills, Results focus, Customer focus, Communication.
• Intermediate Bilingualism – Oral and Written: English and French (Quebec only).
• Strong knowledge of Good Clinical Practice and local regulations;
• Solid clinical background to ensure appropriate comprehension of study indications, study protocols and study related material;
• Strong organization and prioritization skills in order to respond to constantly changing situations and work on multiple projects;
• Strong interpersonal, communication and customer-servicing skills;
• Previous clinical research experience (as a CRA or as a site Clinical Coordinator) is an asset.
• Travel may be required depending on the assigned territory.
• Advanced computer skills: able to learn new software programs quickly; ability to work with different computer systems.