Sr Clinical Research Associate for Sarah Cannon Network

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Sr Clinical Research Associate for Sarah Cannon Network in Nashville, TN

Some responsibilities include:

Duties include but are not limited to:

– Reports directly to Manager, CRA on general issues
– Reports to the Project Manager or Project Lead for study specific issues
– Conduct all activities according to the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements
– Contribute to the departmental on-site Quality Control program by setting a schedule of site assessment visits for the project for agreement with the Services Monitoring Management Team, and conducting agreed co-monitoring visits with members of the Services Monitoring project team.
– Ensure awareness of project-specific quality and performance standards (within Services Monitoring Standards) and ensure that these are adequately documented, communicated, and understood.
– To be accompanied by Project Manager, Project Lead, or CRA Manager on selected visits (qualification, initiation, monitoring, and close out visits.)
– To support the development and delivery of department training days.
– Actively participate in training sessions and workshops, including presenting reports from any conferences attended
– Assist in the Investigator selection and qualification process.
– Assist in the development of patient recruitment strategy.
– Attendance at Investigator Meetings.
– Perform and document pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, company SOPs, applicable regulatory requirements and defined quality and performance standards.
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