This position is responsible for leading and managing day-to-day operations, resources, and staffing for Urology clinical research to ensure efficiency, safety, and compliance. This role is dedicated to responsibly growing research and scientific innovation for our institute and expanding research services and collaborations into our surrounding communities and region. Essential Functions. Oversees and manages day-to-day clinical research operations for clinical research team including but not l... more details
Position Summary
This position is responsible for leading and managing day-to-day operations, resources, and staffing for Urology clinical research to ensure efficiency, safety, and compliance. This role is dedicated to responsibly growing research and scientific innovation for our institute and expanding research services and collaborations into our surrounding communities and region.
Essential Functions
Oversees and manages day-to-day clinical research operations for clinical research team including but not limited to Clinical Research Nurses, Study Coordinators, Regulatory Specialists, Data Specialists, Statisticians, and Research Assistants.
Provide leadership, planning, staff training, implementation, and evaluation of clinical research to ensure proper allocation of resources and finances, participant safety, investigator and sponsor satisfaction, and to ensure clinical trials are carried out in compliance with institutional SOPs, GCPs guidelines, sponsor and protocol requirements, and all applicable local and federal regulatory regulations.
Collaborates with investigators, clinical research team, Urology administration, and ancillary services to facilitate the development of grant proposals, prepare and negotiate study budgets, and monitor accounting.
Develop and establish efficient department-specific systems, strategies, and processes to continuously monitor progress towards achieving objectives, policies, and metrics.
Develop and implement innovative and strategic objectives and policies to improve and expand clinical research opportunities for our investigators and patients.
Under the direction of Urology leadership, provide oversight and expertise for assigned institutional projects and process improvement initiatives.
Manage the finances of the clinical research program including oversight of grants, contracts, study budgets, project expenditures, staff salary distribution, and study supply purchasing, serving as primary liaison between Urology and the grants and contracts offices at both UH and CWRU.
Serve as the primary liaison between human resources, to ensure proper alignment and support for clinical research team recruitment, hiring, onboarding and retention.
Serve as the primary liaison for facility and space planning; assign, allocate and manage research work space.
Develop and manage the short- and long-term budgetary projections for the Urology clinical research program.
Collaborates with ancillary services, including but not limited to Clinical Research Center, Marketing, Laboratory Services, Compliance,
Required For All Jobs
Performs other duties as assigned.
Complies with all policies and standards.
For specific duties and responsibilities, refer to documentation provided by the department during orientation.
Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
Qualifications Education
Bachelor's Degree Required
Work Experience
5 years of clinical research experience Required and
3 years demonstrated management, supervisory or project management experience in clinical research. Required
Knowledge, Skills, & Abilities
Excellent interpersonal, communication, and management skills. Required
Critical thinking, problem solving, and decision-making. Required
Understanding, developing, and deploying staff and their skills. Required
Detail-oriented with the ability to collect, compile, analyze, and present information; excellent verbal, written, and communication skills. Required
Strong organizational and self-motivation skills to achieve goals and objectives. Required
Interpretation and understanding of clinical and research processes and policies, as well as local and Federal regulations. Required
Licenses and Certifications
Society of Clinical Research Associates (SoCRA) Required or
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