To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02764

About our client Our client is a global, publicly traded drug development services company headquartered in New Jersey. The company has strong financial, an experienced management team, and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Clinical Research Associate (Home-Based) Quebec Salary Highly competitive package, commensurate with experience Responsibilities 1) Monitor (pre-study, initiation, routine, and closeout visits) at investigator sites for GCP compliance as per company SOPs and/or client guidelines 2) Generate study specific documentation including monitoring trip reports, telephone contact reports, site correspondence, and expense reports 3) Recruit investigators for participating in clinical trials 4) Conduct project feasibility assessments 5) Negotiate study budgets with investigators 6) Obtain, review for appropriateness, and process regulatory as well as administrative documents from investigator sites 7) Review draft protocols for completeness and feasibility 8) Develop CRFs for clinical trials 9) Participate (e.g. study-specific guidelines and procedures, CRFs, and monitoring conventions) at investigator meetings 10) Prepare and process Serious Adverse Event (SAE) reports, as per plan 11) Resolve queries of CRF data with study-site personnel 12) Prepare project management reports for clients, project personnel, and management 13) Review tables and listings generated from study data 14) Assist in writing clinical study reports 15) Train junior CRAs on monitoring, internal procedures, and query resolution Requirements 1) Bachelor’s degree or RN 2) 2 years of experience in clinical research, drug development, data management, regulatory affairs, or any other healthcare-related field 3) Minimum 1.5 years of experience in field monitoring and site management for a pharmaceutical/biotech company or CRO 4) Excellent organizational skills 5) Ability to manage time and work independently 6) Fluency in French 7) Superb communication (written and verbal) skills 8) Willingness to work in the company office when not traveling 9) Ability and willingness to travel overnight (up to 80%)