Oncology Regional MonitorApply Now

Category: CRA
Location: Home-Based
Salary: TBD

Job Description:

Requirements:

 Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out.
 Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
 Managing, preparing, sending, tracking, and returning investigational supplies at individual sites.
 Monitoring and documenting investigational product dispensing, inventory, and reconciliation.
 Monitoring and documenting laboratory sample storage and shipment.
 Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviation/exceptions, serious adverse events and laboratory abnormalities.
 Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
 Reviewing data queries and listings, and working with the study centers to resolve data discrepancies.
 Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues.
 Maintaining complete and accurate study files, and reviewing files to ensure all appropriate documentation is present.
 Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
 Staff residing in the San Francisco Bay Area may be required to commute to the Company Headquarters office or a client’s office, as required by assigned projects
 Other tasks or responsibilities as assigned.


Job Requirements:

Qualifications – Minimum Required

 Nursing registration or 4-year degree, preferably in a scientific or health care discipline.
 At least 3+ years of independent onsite Industry monitoring experience as a Clinical Research Associate in Oncology Studies.
 Strong preference for candidates with recent Oncology monitoring experience in Phase 2-3 studies.
 Must have availability of a car in good condition, a valid driver’s license, a good driving record, and car insurance.
 Successful completion of the Company hiring process, including interviews and reference checks.


Apply Now

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