Responsibilities - Works collaboratively with the Executive Director and Principal Investigators providing strategic oversight of the research program.
- Develops, directs, implements and evaluates research strategies while coordinating with other departments within the organization that impact all aspects of the clinical trial.
- Oversees Network research program operations and all research staff to ensure that Network research site and locations are in compliance with USOR SOP and ICH GCP guidelines.
- Coordinates the preparation and implementation of a Network research budget and financial reporting system, to include all sites and locations of research.
- Collaborates with senior management in the development of accrual targets and financial objectives.
- Develops accountability standards for all locations to ensure that accrual targets and financial objectives are achieved.
- Prepares research financial reports for the Executive director, Finance manager, Joint policy board, and executive committee.
- Functioning at a highly strategic level, provides leadership and guidance in the development of new processes to improve efficiency and effectiveness of organizational strategic outcomes for clinical trials resulting in the success of the research program.
- Functions as a liaison between corporate research operations, research committees, and practice research sites to communicate research initiatives, opportunities and issues.
- Provides oversight of research processes, SOPs and policies.
- Responsibilities include supervising research staff, training and mentoring, providing or facilitating research continuing education activities, and engaging staff in research initiatives and activities.
- Responsible for encouraging and maintaining research focus for practice working with physicians and leadership to grow and maintain the research program.
- Collaborates with the SRL, physicians of the practice, research committee, and other research management in the process of study selection for the research program.
- Responsible to promote or market research program to the practice, community and referring physicians.
Qualifications - Bachelor's degree in a clinical or scientific related discipline desired, Bachelor's degree in nursing preferred.
- Minimum of 7 years experience in clinical research, preferably in oncology.
- Minimum of 7 years progressive supervisory and people leadership experience in a clinical setting, supervisory experience in a clinical research setting is preferred. Registered Nurses require current licensure in the state of practice.
- Strong leadership skills, ability to manage in matrix environment.
- Excellent communication skills, strong ability to multitask, strong interpersonal skills. Must be able to work in a fast-paced constantly changing environment.
- Knowledge and proficiency in all basic computer programs, windows, excel etc. Special knowledge of GCP and ICH guidelines.
- Ability to read, analyze and interpret technical items such as protocols, informed consent documents, and regulatory documents, ability to solve problems and implement solutions.
- Knowledge of medical terminology, nursing assessment, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology as it relates to clinical trials.
- Basic knowledge of financial management to include budgeting and contracting, understanding of site financials including revenue cycle.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work may require sitting for long periods of time, stooping and bending/stretching for files and supplies. Requires occasional lifting of files or paper weighing up to 30 pounds. Requires manual dexterity sufficient to operate a keyboard, calculator, telephone, copier and other office equipment. Vision must be correctable to 20/20 and hearing must be in the normal range for telephone contacts.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work is performed in an office environment. Involves high levels of contact with patients and public.
