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
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.
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 email@example.com