Clinical Study Manager

Join TriHealth as Clinical Research Site Manager and help shape the future of research at Bethesda North! The Clinical Research Site Manager plays a pivotal role at the intersection of patient care, research strategy, operational leadership, and team development. In this position, you influence both the daily success of clinical trials and the long-term growth of TriHealth's research program. Few roles offer this level of breadth and impact…you shape patient outcomes, drive medical innovation, partner closely with physicians, develop future research professionals, and contribute directly to the strategic advancement of the Hatton Research Institute. Why Join Our Team: Lead a growing research program - Shape the future of clinical research in a respected, mission-driven health system. High-impact leadership - Partner across disciplines and influence research operations, quality, and strategic direction. Advance patient access to innovation - Support trials that bring cutting-edge therapies and new care options to the TriHealth community. Build and develop a strong team - Mentor research staff, strengthen capabilities, and foster a culture of accountability and growth. Drive strategic and operational excellence - Lead protocol evaluation, process improvement, and partnerships that elevate research performance. Enjoy stability and strong benefits - Day-shift schedule with no weekends or holidays, plus comprehensive TriHealth benefits. Location: Bethesda North Hospital at 10500 Montgomery Road, Montgomery, OH 45242 Work Schedule: Full-time (80 hours biweekly) Day Shift No Weekend or Holiday Commitment TriHealth offers a comprehensive benefits package which includes medical, dental, vision, paid time off, retirement plans, and tuition reimbursement. Please view our benefits page: Job Requirements: Bachelor's Degree in Biology, Physiology, Business, Public Health, or related scientific/healthcare field Equivalent experience accepted in lieu of degree Knowledge of GCP, ICH guidelines/regulatory requirements for clinical trial management This position requires strong leadership skills and the ability to manage people, deliver on clinical projects, and align with business initiatives 2-3 years’ experience in Professional Management 3-4 years’ experience Professional Clinical Research Job 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 Responsibilities: Performs feasibility evaluations of accepting potential protocols through analysis of coordinator staffing requirements, resources requirements, clinical considerations and financial profitability. Evaluate need and appropriateness of requests by staff 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 dead 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 office-based research and recommendations. 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 Help implement strategic plans, including developing strategic partnerships with foundations, sponsors, vendors, and clinicians. Lead the implementation of the plan. Other Job-Related Information: Working Conditions: Climbing - Rarely Concentrating - Frequently Continuous Learning - Frequently Hearing: Conversation - Consistently Hearing: Other Sounds - Frequently Interpersonal Communication - Consistently Kneeling - Rarely Lifting Lifting 50+ Lbs - Rarely Lifting 11-50 Lbs - Rarely Pulling - Occasionally Pushing - Occasionally Reaching - Occasionally Reading - Frequently Sitting - Frequently Standing - Frequently Stooping - Occasionally Talking - Frequently Thinking/Reasoning - Consistently Use of Hands - Frequently Color Vision - Frequently Visual Acuity: Far - Frequently Visual Acuity: Near - Frequently Walking - Frequently Leadership Performance Standards TriHealth leaders create a culture of engagement, safety & reliability and high performance by consistently modeling and utilizing the following TriHealth Way leadership competencies, tactics and ALWAYS Behaviors to drive strategic pillar results: Achievement of Annual Pillar Goals: 1) Safety/Quality, 2) Service, 3) Growth, 4) Culture/People, 5) Finance Leadership Competencies: TriHealth Way of Leading TriHealth Way of Serving Transformation Change Drive for Results Build Organizational Talent Leadership Tactics: Conduct department huddles. Generally, clinical departments hold daily huddles, non-clinical hold weekly huddles. Regularly Round on Team Members, using questions from the rounding log. 25 or fewer team members = monthly 26-50 team members = every other month 51+ (and optional team members) = quarterly Lead monthly team meetings using meeting agenda template; review stoplight report; cascade key leadership messages. Model, coach and validate team members’ use of TriHealth Way behaviors (AIDET + Promise, Always Behaviors and Always HEARD). Recognize team members for safety wins, positive performance and demonstrating SERVE and ALWAYS behaviors, TriHealth Way of Leading, Serving and Delivering Care. TriHealth SERVE Standards and ALWAYS Behaviors At TriHealth, we believe there is no responsibility more important than to SERVE our patients, our communities, and our fellow team members. To achieve our vision and mission, ALL TriHealth team members are expected to demonstrate and live the following: Serve: ALWAYS... Welcome everyone by making eye contact, greeting with a smile, and saying "hello" Acknowledge when patients/guests are lost and escort them to their destination or find someone who can assist Refrain from using cell phones for personal reasons in public spaces or patient care areas Excel: ALWAYS... Recognize and take personal responsibility to address and recover from service breakdowns when a customer's expectations have not been met Offer patients and guests priority when waiting (lines, elevators) Work on improving quality, safety, and service Respect: ALWAYS... Respect cultural and spiritual differences and honor individual preferences. Respect everyone's opinion and contribution, regardless of title/role. Speak positively about my team members and other departments in front of patients and guests. Value: ALWAYS... Value the time of others by striving to be on time, prepared and actively participating. Pick up trash, ensuring the physical environment is clean and safe. Be a good steward of our resources, using supplies and equipment efficiently and effectively, and will look for ways to avoid waste. Engage: ALWAYS... Acknowledge wins and frequently thank team members and others for contributions. Show courtesy and compassion with customers, team members and the community Job keywords: Clinical Research Coordinator / Social Science Research Assistant / Clinical Data Manager #J-18808-Ljbffr