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| Job #02390 |
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| About our client |
| Our client is a small biotech company based in Montreal, QC. The company creates and develops therapies to treat brain-related diseases. |
| Position |
Location |
| Senior Clinical Coordinator |
Montreal, Quebec |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
| 1) Coordinate clinical trials 2) Oversee site management and performance (including documentation) of in-house activities for multiple investigational sites 3) Perform administrative duties including attendance at project team meetings, clinical training sessions etc. 4) Oversee if all in-house activities are in accordance with designated project assignment, including applicable SOPs, GCP, etc. 5) Assist in preparation of applicable study documents, for example consent forms, study procedures manuals 6) Identify and inform Clinical Project Manager of any concerns related to quality of services provided 7) Suggest, initiate, recommend or provide solutions 8) Perform other tasks, as assigned by Clinical Project Manager 9) Knowledge of site monitoring, GCP/ ICH guidelines and their application and associated SOPS/work instructions 10) Oversee operations support for assigned projects11) Ensure communication between investigative sites and company 12) Provide assistance to study sites with protocol and regulatory compliance |
| Requirements |
| 1) RN, BSN, BS/MS or BA in Health or Biological Sciences or 1-3 years of related clinical research experience or two-year associate degree 2) 3-5 years of experience in clinical research or a health-related field, or high school diploma or equivalent 3) 6+ years of related experience 4) 2-3 years of monitoring experience 5) Phase 1 experience (preferred) 6) Oncology preferred 7) Knowledge and ability to apply GCPs, ICH and applicable regulatory guidelines 8) Knowledge of procedures for monitoring clinical trials, GCP and medical terminology preferred9) Extensive knowledge of clinical research and operations, prior monitoring experience or equivalent preferred 10) Demonstrated ability to work in a cross-functional manner 11) Proven problem-solving and organizational skills 12) Ability to handle and prioritize multiple tasks 13) Effective communication skills – oral and written 14) Good command of English 15) Effective interpersonal and organizational skills 16) Computer skills in MS Word and Excel program experience preferred 17) Willingness to travel |

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