CCRC Program Manager
Serve as Program Manager of the Clinical Cardiovascular Research Center (CCRC), which also encompasses the cardiology Clinical Trials Unit (CTU). Both CCRC and CTU are accountable through and report up to the Division of Cardiology. The manager is responsible for planning, directing and coordinating all phases of University of Rochester Medical Center investigator-initiated, National Institutes of Health (NIH) and industry funded regional, multi-center and single-center research projects with extensive responsibility for short and long-term strategy development and execution, subject recruitment strategies, administration, staff leadership and supervision, budgetary aspects, subcontracts, protocol development, Standard Operating Procedures (SOPs), data quality, training, and regulatory compliance with considerable latitude for the exercise of independent judgement and initiative.
Plans multi-center or multi-program research projects to insure objectives outlined in the project will be accomplished in accordance with prescribed priorities, time limitations, and funding conditions. Initiates and participates in meetings, evaluates enrolling centers, develops data forms with, and confers with regulatory agencies, IRBs (Institutional Review Boards) and University administration. Prepares project reports and funding applications
Leads and manages the CCRC and Cardiology clinical enrollment unit (CTU) teams. Overall responsibility for a team of approximately 25, including 9 direct reports. Staff management responsibilities include:
Plan staffing levels
With Human Resources support, recruit, interview, select, and hire employees
Provide oversight and direction to employees in accordance with organization policies & procedures
Support new hire orientation and training activities by managers of new staff
Coach, mentor and develop staff
Set and monitor goals & objectives for direct reports, including accountability and performance review process
Consciously create and maintain a workplace culture consistent with ICARE values and high level of employee engagement
Plans single-center, investigator-initiated research projects to insure objectives outlined in the project will be accomplished in accordance with prescribed priorities, time limitations, and funding conditions. Works with and supports clinical faculty in implementing the logistics of investigator-initiated clinical studies. Initiates and participates in meetings, evaluates enrolling centers, develops data forms with SOPs, and confers with regulatory agencies, IRBs and University administration. Prepares project reports and funding applications.
Plans and directs short and long-term strategies of the CTU and oversees decisions on study approval, allocation, and finances. Oversees activities of and assists lead research program manager for patient recruitment and data collection. Responsible for tracking and reporting of patient recruitment metrics and management of all recruitment activities. Trains investigators and coordinators participating in the clinical trial enrollment unit. Follows federal, state and institutional laws and guidelines to access and maintain confidential records related to research patient health information.
Oversees the administrative staff financial reporting system and budgets for research activities including staff allocation and multiple subcontracts. Reports to the director and collaborates closely with department administration on the financial status of the research projects. Reports to the Director of the Clinical Cardiovascular Research Center administration on the financial status of the research projects.
Plans and implements a comprehensive data management and information systems strategy related to CTU and local investigator initiated studies (i.e. URMC Oncore-Clinical Trial Management System, RedCAP, and EPIC),the CCRC multicenter clinical trials (i.e. RedCAP,Trial Master), and the new digital health technology initiative (cloud-based) in conjunction with the computer programming staff, URMC Information Technology and data control staff. Creates processes and new systems, and/or improves efficiency of current state to ensure high level of operation and successful implementation of new technology, systems, or processes in accordance with short and long-term strategy.
Supervises and keeps current with the regulatory reporting guidelines both in the U.S. and overseas and insures compliance with government regulation, reporting requirements and funding requirements including preparation of consent forms, data forms, INDs (Investigational New Drugs) and IDEs (Investigational Device Exemptions).
Plans and directs the administrative and programmatic support for research activities in order to effectively manage available resources such as personnel, space, supplies, computers, and office equipment.
As Program Manager, represents the Clinical Cardiovascular Research Center to both internal University committees and outside organizations involved in the clinical research and administration structure. Acts as a resource to other departments of the University and Medical Center. Serve as member and chair of various support services committees and task forces.
Maintains a strong working knowledge of the cardiovascular research literature and FDA compliance issues both in general and as it relates to the specific tasks assigned through attendance at national meetings and interactions with study sponsors.
Consults and collaborates as study investigator regarding design, preparation, and exploration of special research projects that may include new business or workflow logistics models in clinical trial management methodology including presentation of own research in meetings and publication.
Proven communication, interpersonal, organizational and analytical skills through success in previous clinical research experience.
Demonstrated success in bringing together cross functional teams for effective problem resolution.
Familiar with large academic medical center clinical operations.
Previous experience managing multiple projects simultaneously and managing multi-disciplinary teams.
Experience in startup, contract negotiation, budget preparation, and clinical trial enrolment for industry, investigator initiated, NIH, and NSF sponsored trial.
Deep understanding of clinical quality compliance and study management in clinical research.
Advanced knowledge of Good Clinical Practices (GCPs) and current knowledge of FDA regulations for clinical trials.
Knowledge of academic medical center clinical research billing regulations and risk mitigation.
Knowledge of HIPAA (Health Insurance Portability and Accountability Act of 1996) regulations.
Knowledge and experience with writing reports, research coordinator clinical trial practices, GCPs.
Comprehensive understanding of applicable clinical research regulations in single and multi-site IRB.
Makes strategic recommendations/decisions to meet project goals.
Have an eye for quality and sense for detail, while keeping track of timely delivery.
Proactively implements effective and creative solutions to a variety of problems; ensures solutions are consistent with organizational objectives.
Bachelor’s degree and 5 years of experience in clinical research, preferably management experience; or an equivalent combination of education and experience. Experience as a certified pharmaceutical Clinical Research Associate with nursing degree preferred. Knowledge of software preferred.
Minimum of 8 years of relevant experience highly preferred.
At least 2 years management experience highly preferred.
Master’s degree preferred.
Demonstrated previous ability to lead a large multi-disciplinary team in the development and execution of clinical research projects of any scale or complexity.
Advanced understanding of regulatory, financial and operations issues as they relate to University-wide research and project administration, including the ability to successfully identify and mitigate risks.
HSPP, CLASP, GCP certifications a plus.
Strong direct experience in patient recruitment/enrollment and coordination of clinical (human subjects) research.