Manager 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.

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.
• 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.

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.
• 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.

Qualifications

• Comprehensive, end-to-end experience with company-sponsored research.
• Past experience in managing clinical research teams.
• Experience with regulatory compliance and adherence to FDA, IRB, and IACUC guidelines.
• Ability to work independently and manage multiple projects simultaneously.
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving skills.

Skills

• Strong leadership and management skills.
• Excellent communication and interpersonal skills.
• Proficiency in project management tools and software.
• Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management.
• Experience with budgeting, financial management, and resource allocation.
• Ability to work independently and manage multiple projects simultaneously.

Benefits

• Medical, dental, and vision insurance.
• Paid time off.
• Roth and Traditional 401(k) plans.
• Tuition reimbursement.

Pay

Competitive salary based on experience and qualifications.

Schedule

Full-time (80 hours biweekly), Day Shift, No Weekend or Holiday Commitment.

Location

Bethesda North Hospital at 10500 Montgomery Road, Montgomery, OH 45242.