Clinical Supply Coordinator

Proclinical is currently seeking a Clinical Supply Coordinator to join a leading global advisor of talent supply chain strategies, that aligns talent strategy across all internal and external worker categories.

Joining the team in Jacksonville, the Coordinator will provide clinical research support and assistant in overseeing the conduct of clinical trials.

Job Responsibilities:

• Working to ensure that trials adhere to study protocols, applicable SOPs, FDA regulations, International Conference for Harmonisation (ICH) and Good Clinical Practices (GCP) guidelines, and government regulations.
• Evaluating, monitoring, and documenting study results.
• Exercising good clinical judgment, and demonstrating professional conduct when interacting with investigational site personnel and sponsor representatives.
• Monitoring Clinical Research Organisations (CROs), and studying management of multiple sites.
• Taking responsibility for document retrieval, archival, informed consent release forms, amendments, etc.
• Taking responsibility for the management of designated clinical trials, including investigator recruitment and selection, analysing potential patient recruitment, preparing trial-related documentation, organising Ethics committee submissions with follow through to ensure successful outcome.
• Ensuring procedures are in place for an appropriate optimisation of patients into the clinical trials.
• Planning the requirements for clinical trial material (CTM), ordering CTM, setting up and monitoring the systems whereby the CRA can ship CTM to the investigator, maintain procedures to account for the CTM, checking the expiration of CTM, and requesting extensions if necessary.
• Approximately 15% local on-site monitoring.

Skills and Requirements:

• A bachelor's degree required.
• 1-3 years experience with either medical device research experience, or in-house pharma CRA experience (strictly Regional CRA experience will be considered).
• Experience as a Clinical Research Coordinator (Site-level Study Coordinator) experience is required in lieu of CRA experience.
• On-site monitoring experience is preferred but not required.
• Electronic Data Capture (EDC) experience is required.
• Excellent oral and written communication skills.
• Willingness to travel up to 15% on an as-needed basis throughout the Southeast US for intermittent monitoring.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Maya Smith on 267-405-6995 (5030) or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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