University of Rochester Project Manager - 224082 in Rochester, New York
School of Medicine & Dentistry
Full Time 40 hours Grade 055 Cancer Center M&D
8 AM-4:30 PM
The Research Project Manager oversees a team of (>20) highly skilled and efficient clinical research staff charged with upholding the same expectations and requirements including continued focus on increasing efficiencies, improving quality control, and providing a robust training and education program. In partnership with the Geriatric Oncology Director, oversee and ensure successful delivery and execution of clinical trial operations, Cancer Care Delivery Research (CCDR), including personnel management, and regulatory compliance. Ensures that all institutional, local, state, and federal regulations, good clinical practice (GCPs), ICH, and IRB requirements are met. The positions primary responsibilities include but are not limited to development of strategies for patient recruitment, compliance, performance and quality improvement, operational efficiency, and employee engagement.
The principal investigator for the geriatric oncology clinical protocols, Supriya Mohile, M.D., M.S., will provide direct supervision
Typical Duties: Oversees the development, implementation, and routine updating of Standard Operating Procedures (SOPs) to ensure consistent, safe, and efficient management of clinical trials and continuous improvements in the integrity of clinical trial and research activities; oversees the development and content of grant submissions to maintain a high standard.
Plans and implements a comprehensive data management and information system designed to network participating centers. Develops consistent HIPAA secure procedures for data collection, entry and analysis and established quality control mechanism.
Oversees equipment and software purchases, keeping up to date on the most appropriate and latest innovations.
Provide oversight for generation of monthly reports including but not limited to performance, accrual, monitoring, time to activation, audit visits, and financial performance. Ensure accuracy of clinical trial information in all CTMS, clinical trial and research databases, and tracking systems. Ensure quality, timely, and accurate data and report submission.
Represent the Geriatric Oncology Research Group on Health Systems committees and task forces. Serve as liaison to advance clinical trial and research interests including participation in community outreach; liaison to other University departments and collaborators, NIH, NCI, and external PIs, co-PIs, investigators, pharmaceuticals, and other companies.
Oversees Geriatric Oncology’s social media and website presence.
Provide guidance of Geriatric Oncology financial activity inclusive of the annual operations budget, study specific clinical trial budgets and associated cost recovery, or post-award activities.
Plans and implements multi-center and multi-program research programs.
Support Human Resource activities related to Geriatric Oncology staff.
Hires, trains, supervises, and evaluates program staff. Coordinates multi-center recruitment efforts, and trains investigators and study coordinators for participating centers. Supervises on-site monitoring of participating centers.
Assists in applying for grant funding and in preparing progress reports.
Coordinates multiple research related team-based activities including but not limited to compliance of NIH policies (e.g. data archives; data sharing; clinicaltrial.gov), oversight of data protection, oversight of data management and analyses procedures, and oversight of abstracts and publications.
Oversees processes to ensure scientific integrity of data.
Interacts with local and national research structures including the NCI Community Oncology Research Program Research Base, the Clinical and Translational Science Institute, the Cancer and Aging Research Group and funders including the NIH, PCORI, and foundations.
Promotes and improves upon diversity, inclusion, and equity by ensuring a culture of inclusivity and respect, and by promoting activities between Geriatric Oncology Research Group and others at Wilmot Cancer Institute, URMC, and UR.
Keeps up to date on the latest research, regulations and guidance’s. Machines/Equipment Used:
Computer, Printer, Copier
Position requires a Bachelor's degree with major course work in an appropriate health, social or technical field, 3-5 years of related experience; or an equivalent combination of education and experience. Master’s degree is preferred, with a focus on Health Education, Clinical Research Investigation, or another related field. 5-6 years of clinical trial experience is preferred with evidence of progressive leadership experience.
The candidate should have extensive knowledge in clinical research operations and associated regulations governing clinical research. Strong communication skills (verbal and written). Ability to provide leadership and promote collaboration. Candidate most possess exceptional organizational and time management skills.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled