Clinical Research Manager

TriHealth; Cincinnati (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

A healthcare organization in Cincinnati seeks a Manager of Clinical Research to lead the establishment of a Research Program. The role includes planning, directing, and coordinating department activities with a focus on regulatory compliance and quality improvement. Candidates should possess a Bachelor's degree and extensive experience in clinical research along with strong leadership skills to guide project initiatives. This position offers an opportunity to foster collaboration and enhance the research capabilities of the organization.

Qualifications

• Bachelor's Degree in a relevant scientific or healthcare field.
• 2-3 years of professional management experience.
• 3-4 years of experience in clinical research.
• Strong leadership skills and ability to manage clinical projects.

Responsibilities

• Evaluate feasibility of protocols through resource and financial assessments.
• Ensure compliance with IRB/IACUC/FDA requirements.
• Oversee training needs and orientation for research staff.
• Develop strategic partnerships for program development.
• Implement planned strategies to improve clinical research.

Skills

Leadership skills

Clinical trial management

Knowledge of GCP

Analytical skills

Education

Bachelor's Degree in Biology, Physiology, Business, Public Health, or related field

Job description

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 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

Working Conditions: Climbing - Rarely, Concentrating - Frequently, Continuous 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.