Program Manager

3 weeks ago


Cleveland, United States Cleveland Clinic Full time

NOTICE OF FILING APPLICATION FOR PERMANENT EMPLOYMENT CERTIFICATION Employer: Cleveland Clinic, 9500 Euclid Avenue, Cleveland OH, 44195 Title: Program Manager, Taussig Cancer Center Worksites: Taussig Cancer Center Cleveland Clinic, 9500 Euclid Avenue, Cleveland OH, 44195 **Duties:** The Program Manager, Taussig Cancer Center at Cleveland Clinic's Main Campus (9500 Euclid Avenue, Cleveland, OH 44195) oversees and manages start-up and implementation of multi-site investigator initiated research trials (IITs) and Investigational New Drug (IND) applications. He or she develops and maintains research trial protocols, and oversees full implementation of clinical trials, including: ensuring compliance with clinical research protocols, managing schedules and trial deadlines, reviewing adherence to internal HR policies and corporate compliance procedures, and helping prepare budget and resource allocation for clinical research program. Responsibilities include: supporting pre-site selection, ensuring funding and protocol resource support is secured, handling Protocol Review and Monitoring Committee (PRMC) and medical Institutional Review Board (IRB) submissions; drafting and reviewing all IIT study regulatory documentation in collaboration with principal investigator (PI); handling national regulatory agency (e.g. FDA) and all other regulatory compliance submissions for high-risk and multi-site IITs and IND applications; developing IND protocols and study materials; reporting serious adverse events; serving as a liaison between investigators, research personnel, and research administration office to assist in protocol interpretation, enrollment, and safety questions; conducting informed consent process; and completing data abstraction and entry for patient enrollment. He or she also trains research coordinators working on low-risk or single-site IITs within Taussig Cancer Center when needed. Occasional telecommuting permitted. **Requirements:** At minimum, the position requires a Bachelor's Degree in Biology, Health Sciences, or related field or foreign equivalent as evidenced by a credentials evaluation. Employer defines foreign educational equivalent to include a combination of degrees and/or professional experience recognized by a certified independent credentials evaluator as an academic equivalent to a Bachelor's Degree in Biology, Health Sciences, or related field. Position also requires three (3) years of clinical research coordination experience. Stated experience must include: handling national regulatory agency submissions; overseeing compliance with clinical research protocols; conducting start-up and regulatory maintenance of investigator-initiated trials; and completing data entry. **Salary:** Commensurate with qualifications and experience ($75,400/year). **Contact:** Jessica Greig GREIGJ2@ccf.org This notice is posted as a result of the filing of an application for permanent alien labor certification for the position of Program Manager. Any person may provide documentary evidence bearing on the application to the Certifying Officer of the Department of Labor, pursuant to 20 C.F.R. * 656.10(d). The address for the appropriate Certifying Officer is: U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N- 5311 Washington, DC 20210 Salaries [which may be] shown on independent job search websites reflect various market averages and do not represent information obtained directly from The Cleveland Clinic. Because we value each individual candidate, we invite and encourage each candidate to discuss salary/hourly specifics during the application and hiring process. Cleveland Clinic Health System is pleased to be an equal employment employer: Women / Minorities / Veterans / Individuals with Disabilities



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