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 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 Professional Management
3-4 years experience Professional Clinical Research
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 fo
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 reco
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
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 - Rarely
Concentrating - Frequently
Continous Learning - Frequently
Hearing: Conversation - Consistently
Hearing: Other Sounds - Frequently
Interpersonal Communication - Consistently
Kneeling - Rarely
Lifting <10 Lbs - Frequently
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. |