Sr. CRA (in House Role) - MedFocus (California)
Sr. CRA In house Role
Full time position
Excellent pay, benefits and growth opportunities at a great patient focused company.
Job Description:
* Drive start-up activities at U.S. study sites
* Provide site management and monitoring for assigned clinical trial(s) and ensure protocol requirements, regulatory guidelines, and study timelines are met
* Support the management of monitoring activities at clinical trial sites to assure adherence to Good Clinical Practices (GCPs) and study protocols
* Provides guidance with the development of the trial‘s protocol, Informed Consent Form, CRFs, monitoring plan, site reference materials, and other study related materials
* Conduct pre-study, study initiation, interim monitoring, and close out visits and completes associated monitoring visit reports and follow up letters to investigators
* Assist with inspection-readiness activities for regulatory agencies.
* Assist in the planning of and participates in investigator meetings.
* May assist with the development and negotiation of site budgets
* Minimal Travel required
Requirements:
* Minimum BS / BA (science or health care field) or nursing degree
* 6 or more years‘ experience as a CRA or field monitor at in a pharma or CRO setting
* Oncology experience preferred.
*Min Salary:* $0.00
*Max Salary:* $0.00
*City:* Menlo Park
*State:* CA