Dir, Research Ops
This is a senior-level exempt management position that works collaboratively with the Executive Director and Principal Investigators, providing strategic oversight of the research program.
About the Role
Develops, directs, implements, and evaluates research strategies while coordinating with other departments within the organization that impact all aspects of clinical trials. Provides leadership and guidance in developing new processes to improve efficiency and effectiveness of organizational strategic outcomes for clinical trials. Oversees research processes, SOPs, and policies, ensuring compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP), and applicable federal, state, and local regulations. Supports and adheres to the US Oncology Compliance Program, including the Code of Ethics and Business Standards.
Responsibilities
- Provide strategic oversight of the research program in collaboration with the Executive Director and Principal Investigators.
- Develop, direct, implement, and evaluate research strategies while coordinating with other organizational departments.
- Oversee Network research program operations and all research staff to ensure compliance with USOR SOP and ICH GCP guidelines.
- Coordinate the preparation and implementation of a Network research budget and financial reporting system for all research sites and locations.
- Collaborate with senior management in developing accrual targets and financial objectives.
- Develop accountability standards for all locations to ensure accrual targets and financial objectives are met.
- Prepare research financial reports for the Executive Director, Finance Manager, Joint Policy Board, and Executive Committee.
- Act as a liaison between corporate research operations, research committees, and practice research sites to communicate research initiatives, opportunities, and issues.
- Supervise research staff, provide training and mentoring, facilitate continuing education activities, and engage staff in research initiatives.
- Encourage and maintain research focus for the practice, working with physicians and leadership to grow and sustain the research program.
- Collaborate with the SRL, physicians, research committee, and other research management in the study selection process for the research program.
- Promote and market the research program to the practice, community, and referring physicians.
Requirements
- Bachelor’s degree in a clinical or scientific related discipline (Bachelor’s degree in nursing preferred).
- Minimum of 7 years of experience in clinical research, preferably in oncology.
- Minimum of 5 years of supervisory experience in a clinical research setting is preferred.
- Registered Nurses require current licensure in the state of practice.
- Strong leadership skills and ability to manage in a matrix environment.
- Excellent communication, multitasking, and interpersonal skills.
- Ability to work in a fast-paced, constantly changing environment.
- Proficiency in basic computer programs (Windows, Excel, etc.).
- Specialized knowledge of GCP and ICH guidelines.
- Ability to read, analyze, and interpret technical items such as protocols, informed consent documents, and regulatory documents.
- Problem-solving skills and ability to implement solutions.
- Knowledge of medical terminology, nursing assessment, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, and oncology as it relates to clinical trials.
- Basic knowledge of financial management, including budgeting, contracting, and understanding of site financials, including the revenue cycle.
Working Conditions
- Traditional office environment.
- Large percentage of time performing computer-based work.
- Occasionally lifts and carries items weighing up to 40 lbs.