The Senior Clinical Research Associate (Sr. CRA) performs routine site visits to ensure that the rights and wellâ€‘being of human subjects are protected; the reported trial data are accurate, complete, and verifiable from source documents; and that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), SOPs, GCP/ICH Guidelines, and other applicable regulatory requirements. Additionally, the Senior Clinical Research Associate assists in training and mentoring other regional monitoring personnel. In doing this, the Senior Clinical Research Associate represents OptumInsight and the sponsor to site personnel and colleagues with professionalism and integrity.
Â· Perform routine site visits, including pre-study, initiation, interim, and closeout visits. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements and assurance of good site performance. This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.
Â· Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
Â· Report to OptumInsight project team, client, and site personnel any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines. Significant issues noted must be reported to appropriate personnel immediately.
Â· Maintain Cube or alternative project tracking system of subject and site information.
Â· Serve as back up for Line Manager or Lead CRA when required.
Â· Provide training for colleagues on clinical, regulatory, administrative, and company procedures and processes.
Â· Participate in feasibility studies.
Â· Assist with companyâ€™s quality control initiative.
Â· Present study materials at Investigator/study launch meetings when required.
Bachelorâ€™s level degree in life sciences, pharmacy, nursing or RN preferred
Â· Four or more years of clinical monitoring experience
Â· Strong knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Â· Proven ability to work independently in a fast-paced environment
Â· Strong communication, interpersonal, and organizational skills
Â· Must demonstrate good computer skills
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