CLINICAL RESEARCH ASSOCIATE (CRA)

GVI Clinical Development Solutions Inc. (GVI CDS) provides strategic consulting and hands-on clinical development support to biotechnology, pharmaceutical, diagnostic, medical device, and nutraceutical companies. A Contract Research Organization (CRO), GVI CDS provides biotech and pharma companies with quality, cost-effective services including regulatory and clinical path mapping, experienced site monitors, full-service clinical outsourcing, and/or post-market pharmacovigilance.

Reports to: President

Location: Winnipeg, MB., Canada

Job Description:

The Clinical Research Associate (CRA) will be responsible for organizing and administering clinical trials of new and current drugs with the aim of assessing their benefits, risks, and effects. He/she will collaborate with clients and coordinate all aspects of the clinical program(s), ensuring timely completion of work and maximum efficiency while meeting budgetary requirements.

  •   Identify, initiate, and close study centers.
  •   Identify and brief appropriate trial investigators (clinicians).
  •   Provide input on trial materials and instructions to clinicians on how to conduct trials.
  •   Monitor progress throughout duration of the trial.
  •   Collect and authenticate Case Report Forms.
  •   Write trial reports.
  •   Liaise and negotiate in a professional manner with clients and clinical investigators regarding all aspects of the project(s).
  •   Inspire teamwork between all parties of the project(s).
  •   Participate in the establishment and management of the Clinical Department and initiate improvements to enhance efficiency of the department and improve the quality of the work performed.

Requirements:

  Bachelor's degree in health or 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 5 years’ experience in clinical research or related research field with 2 years’ direct experience as a clinical research associate.
  •   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).
  •   Must be a self-starter with a proven ability to work with minimal supervision.
  •   Excellent verbal and written communication skills with the ability to negotiate and liaise internally and with clients and investigators.
  •   Ability to travel up to 60% or as required.

Interested candidates should email their cover letter and resume to careers@gvicds.com