Wednesday, 29 January 2014

131817BR


Pharma
Pharma - Oncology
Canada
Toronto
Novartis Pharma Canada
Development & Medical
Oncology
Full Time
Temporary
Job Purpose

Ensure that clinical trials are conducted in Canada according to Novartis SOPs, Health Authority
regulations and Good Clinical Practice.

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;

Act as primary contact for investigational sites under his / her responsibility.
Education :
B.Nursing, B.Sc., M.Sc., B.Pharm., PhD, MD

Years of experience:
2+ years in clinical research

Other: 
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 customerservicing
skills;
Previous clinical research experience (as CRA or as a
site Clinical Coordinator) is an asset.                                               Apply

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