Provide Oversight and Coordination of Sparrow Cancer Center's Clinical Research Assistant (CRA) activities and administrative functions, ensuring the Cancer Center's adherence to the requirements of Sparrow Health System's (SHS) Institutional Research Review Committee (IRRC) which serves as a local Federally mandated review board for all SHS-based human subject research.
This job description is intended to cover the minimum essential duties assigned on a regular basis. Associates may be asked to perform additional duties as assigned by their leader. Leadership has the right to alter or modify the duties of the position.
Coordinates, facilitates, and maintains all Cancer Center's clinical trials administrative functions that facilitate adherence to the requirements set forth by SHS IRRC and all applicable Federal and State regulatory agencies.
Responsible for orientation and training of onboarding CRA's
Ensures that Cancer Center clinical trial studies are compliant with State and Federal regulatory requirements for research involving human subjects.
Responsible for accurate interpretation of regulations, policies, and procedures for the clinical trial nurse and investigators
Responsible for overseeing the CRA team's analysis of protocol information for proposed clinical trial studies, including evaluation of resource/expenditure needs, review of regulatory requirements, assessment of patient eligibility for proposed clinical trials, and cunsultation with physicians to verify patient's appropriateness for entry.
Responsible for the performace of the randomization process
Responsible for the timely submission of the clinical trial application, approved protocol, amendments, notices, suspensions, adverse event rports, study reviews, study closure notices, and termination documentation to the IRB and all applicable regulatory agencies for review, approval, and re-approval
Responsible for oversight of the CRA team's function related to timely submission of IRB applications
Responsible for maintaining an administrative file for protocol documents, trial sponsor correspondence, IRB correspondence.
Maintains and monitors patient case records for accuracy, quality of data, and compliance with protocol guidelines
Responsible for and oversight of activities related to compiling and maintaining clinical trial findings, generating reports, and utilizing clinical trial appropriate check lists and templates and software systems to record data.
Responsible for chart review, timely data collection and submission for audits (i.e. CCOP); attend audits at St. Joseph when scheduled. Report results back to PI and research staff
Responsible for specimen processing, storage, and shipment
In cooperation with the Principle Investigator, identify and record standards of care versus trial related requirements.
Coordinate and maintain trial related activities.
Responsible for oversight of the CRA team's roles and responsibilities surrounding the weekly trial review meetings.
Provides internal correspondence and education to staff regarding protocol specifics and serves as a resource regarding clinical trials questions and available trials.
Responsible for monthly statistical reports on current and available trials including information on active protocols, number of patients enrolled, adverse events, and IRB status
Responsible for scheduling study monitor's site visits, arranging meetings with the PI and pharmacist to discuss the study; Provides the monitor with an update on any study-related issues and ensures that the appropriate patient records will be available for review at the time of the monitoring visit
Oversees the CRA team's role of ensuring that all data queries received to date have been resolved to the extent possible
At the conclusion of monitoring visits, meets with the study monitor to discuss any issues related to adherence to the protocol, review of regulatory files, verification of data in the CRFS with source documentation, assist the pharmacist with any questions regarding study drug storage, dispensing and accountability requirements for data storage
Ensures that issues identified for resolution or follow-up at the monitoring visit are addressed
Certification in Clinical Trials Management or Clinical Research preferred
Minimum of 3 years research experience required Oncology and hematology related clinical trials experience preferred
Bachelor's degree health related field required Master's degree health related field preferred
Specialized Knowledge and Skills
Must have knowledge of federal regulatory requirements related to clinical trials. Must be detail oriented and comfortable working independently. Must be proficient in use of Word, Excel, Access, PowerPoint, Outlook. Excellent verbal and written communication skills required. Project management experience preferred
Sparrow Health System is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.