Clinical Research Project Manager Breast Cancer - Cancer Center Protocol Office
Clinical Research Project Manager Breast Cancer - Cancer Center Protocol Office
Posted on :
10-04-2025
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1 Vacancy
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Job Description
BA/BS or equivalent work experience in industry or other health care setting. Minimum of 25 years related clinical research experience required. Professional clinical research certification desirable. Previous supervisory experience desirable. Strong knowledge of oncology clinical practices and federal regulations governing research. Excellent oral and written communications skills. Selfdirected resourceful highly motivated and energetic. Possess excellent organizational skills and the ability to prioritize critical tasks. Ability to convey information and manage staff of different backgrounds ability and communication skills.Responsibilities as part of management team: Orient and train new staff Mentor junior staff Assist staff with task prioritization for project assignments May provide firstline supervision to research staff May be responsible for new hire/correction action/performance evaluation process for research staff Assist with the design and implementation of departmental quality control measures Proctor meetings supply meeting materials and develop groupspecific tools for a disease group Work with sponsors to resolve monitoring issues Schedule and facilitate preactivation activities including presite qualification visits SIVs and facility tours Assess continuing education needs for disease group staff Identify changes associated with Standard Operating Procedures and develop processes to ensure compliance Data management responsibilities may consist of the following: Verify patient eligibility via chart abstraction and analysis of case data Collect and interpret data necessary for enrollment; register patients appropriately Communicate treatment randomizations to physicians Implement and monitor procedures to ensure protocol compliance Manage data collection via chart abstraction and submit data in timely fashion Monitor and report adverse events as required by institutional/federal regulations Administer Quality of Life and pain assessment evaluations to patients Coordinate and procure investigational drug supplies Resolve data discrepancies Coordinate and process tissue samples as required by protocol Prepare IRB submission of protocol revisions safety reports annual progress reports Assess impact of new risk information on consent documents and revise appropriately Organize and attend on and offsite Investigator meetings to establish procedures Organize and prepare for monitoring visits and both internal/external audits Monitor affiliate site patient data; implement procedures to ensure compliance The Clinical Research Project Manager works closely with the Clinical Research Program Manager Senior Program Manager and/or Associate Director in the areas of Quality Control and Training & Development. The Project Manager provides input into the assessment of departmental procedures and disease group management while maintaining a working knowledge of all aspects of clinical research data management.
Required Experience:
IC
Employment Type
Full-Time
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