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Regional Senior Clinical Research Associate
4 weeks ago
The Senior Clinical Research Associate (Sr. CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH E6 Good Clinical Practices, FDA guidelines, local regulations and standard operating procedures.
Responsible for performing the clinical monitoring aspect of designated projects in accordance with applicable SOPs; performing clinical on-site monitoring activities (e.g. monitor patient recruitment, review consent forms for each patient, source data verification, drug accountability, data collection), collecting regulatory documentation, performing qualification, initiation, monitoring and termination visits of investigational sites, writing visit reports and completing all follow up actions in accordance with ICH GCP guidelines.
CANDIDATES MUST LIVE IN BRITISH COLUMBIA OR NOVA SCOTIA
BILINGUAL ENGLISH/FRENCH REQUIRED
Position Type: Contract and Salaried roles
Desired Knowledge and Abilities:
- Proven clinical monitoring skills.
- Demonstrated understanding of medical terminology.
- Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures.
- Flexibility; ability to travel up to 60-70%
- Remote flexibility
REQUIREMENTS: (APPLICANTS WILL NOT BE CONSIDERED WITHOUT THESE REQUIREMENTS)
- BA/BS or RN degree required.
- Study start up experience required
- 4-5+ Years of monitoring experience, including strong start-up experience (CSAs will be conducting PSVs, compiling US IRB submission packages, reviewing ICFs, and compiling/reviewing US-based regulatory packets for site activation and IP release
- Previous Sickle Cell/Hematology or Respiratory experience.
