Manager Clinical Research-Hatton Research
: Job Details :

FTE-Full Time 80 hours-BiweeklyShift-DaysJob Overview:The Manager of Clinical Research is responsible for establishing and maintaining a Research Program for the TriHealth Hatton Research Institute. The Manager shall have 24-hour accountability for planning, organizing, directing, and coordinating the department's activities. This includes human resources, financial management, program development, department environment and customer service issues. Additionally, this position requires ongoing monitoring and evaluation of FDA/HHS, USDA, AAALAC regulations and requirements specific to human subject (as appropriate) in order to maintain departmental compliance with these regulatory agencies. This position provides departmental support for Hatton and the TriHealth strategic plans and fosters continuous quality improvement and staff development. The Manager of Clinical Research stays informed of national trends and clinical research initiatives at other leading centers. This position possesses knowledge of research operations across a healthcare system or pathophysiology, pharmacology, medical diagnostics and treatment. The Manager of Clinical Research thinks strategically, evaluating where to put the most effort to achieve optimal results.Job Requirements:Bachelor's Degree in Biology, Physiology, Business, Public Health, or related scientific/healthcare fieldEquivalent experience accepted in lieu of degreeKnowledge of GCP, ICH guidelines/regulatory requirements for clinical trial managementThis position requires strong leadership skills and the ability to manage people, deliver on clinical projects, and align with business initiatives2-3 years' experience Professional Management3-4 years' experience Professional Clinical ResearchJob Responsibilities:Performs feasibility evaluations of potential protocols through analysis of coordinator staffing requirements, resources requirements, clinical considerations and financial profitability.Complies with all IRB/IACUC/FDA requirements in study submission to a central or local IRB. Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment. Assures compliance with IRB/FDA standards and deadlines are met.Recognize logistical and technical challenges with respect to the assigned specialty's clinical trial planning and implementation, recommending solutions and alternatives. Identify opportunities for timeline improvements for our internal research process.Responsible for identifying training needs of the specialty area's research staff along with the orientation of new employees, ensuring all are properly oriented and aware of the expectations of their position. Develop educational programs for staff and ensure proper training and understanding.Help implement strategic plan, including developing strategic partnerships with foundations, sponsors, vendors, clinicians. Lead the implementation of the plan.Other Job-Related Information:This role will oversee Women's Health, Ortho/Neuro, and graduate medical education areas of Hatton Research.Working Conditions:Climbing - RarelyConcentrating - FrequentlyContinuous Learning - FrequentlyHearing: Conversation - ConsistentlyHearing: Other Sounds - FrequentlyInterpersonal Communication - ConsistentlyKneeling - RarelyLifting