Mgr, Clinical Trials Proj (L) - University of Rochester

GENERAL PURPOSE: The Sr. Clinical Research Project Manager assumes responsibility for clinical trials project management operations of the URCC PEAK Human Performance Science Program under supervision from the Director of PEAK. This position requires strong management and interpersonal skills, with a background in the management of clinical research activities and project management. In addition, due to the specialized nature of the PEAK Human Performance Science Program, this position requires expertise in exercise oncology and behavioral oncology. This individual will have responsibility for compliant administrative and regulatory conduct of the studies as a liaison between Study Chairs, NCI and other NIH institutes, URCC NCORP Research Base Leadership, URCC Operations Office cross functional teams, WCI leadership and investigators, departmental personnel, and external collaborators at other NCI designated cancer centers. This individual will oversee a team of assigned Clinical Research Project Managers and be responsible for the timely development, launch, conduct and close out of large, national, multi-site clinical trials. This includes creating and maintaining best practices and SOPs for the entire PEAK Program and all day-to-day activities within the clinical laboratory spaces. This individual is also responsible for ensuring that assigned project management staff are appropriately resourced and adhering to policies and procedures. **JOB DUTIES AND RESPONSIBILITIES:** **PEAK Management** + Directs the planning, implementation and coordination of clinical trials run through the PEAK Human Performance Science Program. Is responsible for efficient conduct of the assigned projects from study start up, to data collection, closure and data analysis. Serves as the liaison to the Principal Investigator, URCC leadership, and all key stakeholders. Ensures all research team members understand scope of each project and individual responsibilities. Allocates and assigns personnel and technical resources to meet specific study and general research needs. + Engages with Finance for PEAK budget development and budget management. + Oversees and approves purchasing of equipment for PEAK + Responsible for maintenance and upkeep of physiologic testing equipment and supplies + Has high level knowledge in behavioral and exercise oncology research and physiologic testing protocols and equipment + Assists in the development and creation of both project-specific documents used at multiple institutions such as protocols, source materials, recruitment materials and database forms, and cross-project documents such as policies and procedures. + Manages PEAK study staff, interns and student employees + Collaborates with Primary Investigators with protocol writing, physiologic testing, study start up, implementation, data capture, and data processing **Oversight of assigned study personnel** Including orientation, training, documentation of core competencies, certification mandates, safety/responsible conduct of research education and performance evaluations, including the following tasks: + Manages the day-to-day operations, issue resolution, and supervision of assigned staff + Completes annual performance evaluation process; ensures fair and accurate evaluation following standards of performance. Provides counseling and constructive feedback for employee development + Addresses disciplinary issues + Carries out all actions as to hiring, transfers, promotions and terminations of clinical research staff + Performs QA and supervision of team clinical trial project timelines, adherence to procedures, and all other activities + Participates in staff recruitment and retention initiatives **URCC NCORP research study development** + Works directly with Primary Investigators to develop exercise interventions and physiologic tests to best represent their study outcomes + Tracks and documents research milestones and activities conducted through URCC’s national network for the purpose of meeting NIH goals + Assists with the coordination of all phases as it relates to the URCC NCORP Research Base’s study start-up, data reporting, and close-out of research projects + Assists in the training, onboarding, and participation of national community site personnel at external institutions + Communicates frequently with external institutions to assure compliance with multicenter research activities and provides direction for those institutions in regard to research compliance, training, recruitment, and reporting + Recruits, hires, and manages >50 NCORP study interventionists (e.g., psychologists, nurses, dieticians, counselors, exercise physiologists, physical therapists) **Complies with Good Clinical Practice and the Code of Federal Regulations** + Creates and maintains standard operating procedures for equipment and processes used in the PEAK Human Performance Science Program + Requires a thorough understanding of proposed and active protocols + Provide professional direction for projects to PEAK staff, University Primary Investigators, and division leadership + Prepare for internal and external audits **Professional Development** + Maintain working knowledge of the specialty as well as the current regulations, industry standards and good clinical practices for conducting individual protocols + Attend meetings and pertinent seminars in academic settings Other projects and duties as assigned. **QUALIFICATIONS:** + Bachelor's degree and 6 years of clinical trials experience required + Master's degree preferred + 5 years of experience in clinical research, project management, or relevant work experience or equivalent combination of education and experience required + Previous leadership experience required + Clinical trials project management experience including extensive knowledge of protocol planning, implementation, coordination, evaluation, and reporting of clinical trials required + Strong verbal and written communication skills, interpersonal skills, attention to detail and organization required + Demonstrated leadership skills and competency. Ability to effectively manage complex research protocols/procedures preferred + Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines and standards. Proficiency in managing multiple and competing priorities/demands preferred + Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, and applicable safety standards, throughout study implementation preferred + Exceptional interpersonal, organizational, and time management skills; highly collaborative, promotes teamwork preferred + Ability to build collaboration among research team members, PEAK staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, and empathy for patients) preferred + Proficient in MS Office (e.g., Word, Excel, and PowerPoint), email, and internet preferred + Possesses a high degree of self-motivation; recognized ability to function independently preferred + Proficient in physiologic testing equipment and procedures (Biodex, Electromyography (EMG), G-Studio accelerometry, Bioelectrical Impedance, metabolic testing (resting energy + expenditure, sub-max and maximal VO2 testing), Heart rate variability, actigraphy, wearable activity tracking) preferred + CCRP - Certified Clinical Research Professional upon hire preferred + Certified Project Management Professional (PMP)-PMI upon hire preferred + Professional Research Coordinator certification (SoCRA or ACRP) preferred + Project Management preferred + American College of Sports Medicine (ACSM) certified clinical exercise physiologist required + American College of Sports Medicine (ACSM) certified cancer exercise trainer required + CPR/AED BLS certification required The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations. **How To Apply** All applicants must apply online. _EOE Minorities/Females/Protected Veterans/Disabled_ **Pay Range** Pay Range: $75,650 - $113,464 Annually _The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._ Apply for Job + Careers + Sign In + New User **Location:** School of Medicine & Dentistry **Full/Part Time:** Full-Time **Opening:** **Schedule:**