Job Description

• Work to ensure that trials are adhere to study protocols, applicable SOPs, FDA regulations, International Conference for Harmonization (ICH) / Good Clinical Practices (Google Cloud Platform) guidelines, and government regulations.
• Evaluate, monitor, and document study results.
• Exercise good clinical judgment and demonstrate professional conduct when interacting with investigational site personnel and sponsor representatives.
• Monitor Clinical Research Organizations (CROs) and study management of multiple sites.
• Additional duties include: document retrieval, archival, informed consent release forms, amendments, etc.
• Responsible for the management of designated clinical trials including investigator recruitment and selection, analysis of potential patient recruitment, preparation of trial related documentation (protocols, case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing Ethics committee submissions with follow through to ensure successful outcome, investigator and study staff training.
• Ensure procedures are in place for appropriate optimization of patients into the clinical trial.
• 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, maintaining procedures to account for the CTM, checking the expiration of CTM, and requesting extensions if necessary.
• Approximately 15% local on-site co-monitoring

• Bachelor's degree required
• 1-3 years combined experience with at least one of the following:
• Medical device research experience
• In-house pharma CRA experience (strictly Regional CRA experience will be considered)
• Clinical Research Coordinator (site-level Study Coordinator) experience is required in lieu of CRA experience
• On-site monitoring experience is required
• Electronic Data Capture (EDC) experience required (non-discriminatory)
• Excellent oral and written communication skills

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