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Job #02811

About our client Our client is a global pharmaceutical company headquartered in Thornhill that is focused on the development and manufacturing of various dermatology therapeutics. The company has marketed products, an experienced management team, and an empowering corporate culture that is focused on the professional development of its employees; this is a great opportunity for the right candidate! Position Location Logistics and Documentation Manager/Clinical Research Coordinator Thornhill, Ontario Salary Highly competitive package, commensurate with experience Responsibilities 1) Devise and maintain systems for the coordination of trial activity 2) Prepare trial materials for site (e.g. investigator file, study supply shipments, and CRF books) 3) Maintain Investigator database 4) Prepare trial materials for CRAs (e.g. monitor packages, handbooks, etc.) 5) Distribute and log protocols, amendments, and investigator’s brochures 6) Maintain contact with members of a Trial Team on a regular basis 7) Respond to site and CRA requests and queries (as needed), and redirect as required 8) Ensure drug reconciliation and returned medication shipments to overseas company facility are completed according to local procedure 9) Prepare master file documents 10) Ensure that study payment system is maintained properly 11) Maintain a Trial Master File or Local Trial File according to company SOPs 12) Perform QC release of study medication 13) Provide on-job training in the field according to the documentation collection 14) Prepare the local trial file for archiving by the Archive Manager 15) Work closely with CRA(s) to ensure that documents are in compliance with ICH-GCP and SOPs prior to forwarding to Trial Master File 16) Participate (when requested) in audit process 17) Liaise with the Clinical Project Manager to determine protocol specific training requirements and aid the Clinical Project Manager in preparing training material 18) Coordinate trial logistics and the collection of study documents according to ICH-GCP guidelines and company SOPs 19) Contribute to the quality of research that the department produces in North America by coordinating the logistical aspects of trials 20) Remain current on annual changes in SOPs 21) Ensure that trial administration and coordination of study logistics is carried out promptly and efficiently 22) Assist with projects in Regulatory Affairs (as required) Requirements 1) B. Sc. (preferably in Health Sciences or a related field) 2) Minimum 1 – 2 years of pharmaceutical clinical research experience 3) In-depth knowledge of GCP guidelines 4) Superb leadership and interpersonal skills 5) Well-organized and detail-oriented individual 6) Flexibility to work well – both in a team environment and independently 7) Ability to work independently and prioritize tasks effectively 8) Proficiency in MS Office and Windows 9) Excellent communication skills (written and verbal)