Manager of Clinical Research Operations
About The Position
As the Manager of Clinical Research Operations, you are responsible for management of clinical research operations that include nursing, pharmacy, laboratory and medical assistants to support enrollment through treatment and follow-up visits, and other tasks supporting care of clinical trial patients. This role involves overseeing daily activities, patient enrollment, ensuring protocol adherence, problem-solving, collaborating with study operations, tracking performance metrics, attending meetings, ensuring training completion, identifying process improvements, managing hiring and onboarding, assisting in clinic as needed, meeting with direct manager and physicians, and managing the performance and professional development of the clinical research team.
Requirements
- Associate Degree required
- Registered Nurse License to practice in the state of Florida; appropriate education and/or experience can be substituted
- At least one year of management experience
- Knowledge of oncology/research operational and clinical proficiency
- Knowledge of Good Clinical Practices (GCP)
- Knowledge of research protocol interpretation, and SCRI organizational policies
- General knowledge of research regulatory and Quality Assurance guidelines
- Strong interpersonal, communication and organizational skills
- Microsoft 365, Word, Excel, PowerPoint and overall computer systems
- Ability to communicate and collaborate effectively with a diverse team of professionals internally and externally
- Ability to self-direct, including prioritization of multiple simultaneous tasks to drive the navigation of clinical research patients
- Resourceful with analytical abilities and problem-solving skills in a fast-paced environment
Nice To Haves
- Bachelor Degree preferred
- BLS certification preferred
Responsibilities
- Oversee and manage daily activities of clinical research nurse, enrollment nurse, medical assistant, laboratory technician, pharmacist and pharmacist technician
- Oversee enrollment of patients onto clinical trials through recruitment, screening, enrollment, on study treatment and follow up of eligible patients according to protocol requirements
- Oversee clinical trial related activities are completed by the clinical research team to ensure completeness and accuracy, as well as adherence Standard Operating Procedures
- Problem-solve daily clinical situations for the diverse clinical research team
- Ensures clinical team collaborates with Study Operations to resolve queries, SAEs, deviations and audit findings according to standard operating procedures, regulatory compliance and contractual sponsor obligation
- Escalate issues to leadership when necessary for timely resolution
- Track performance metrics and report monthly to leadership
- Attend mandatory meetings, site initiation and other meetings which will impact the delivery of quality research and compliance
- Ensure clinical team completes company provided and sponsor provided training timely
- Identify opportunities for improvement in processes and overall quality, monitors outcomes if deficiencies are identified
- Responsible for hiring, onboarding, and training of clinical research team
- Assist clinical research team in clinic as needed
- Meet with direct manager weekly to provide clinic summaries
- Meet with physicians and leadership to assess performance of clinic as needed
- Assist in development and tracking of quarterly goals for clinical research team
- Manage performance and professional development of clinical research team by conducting quarterly and annual performance reviews
Benefits
- Comprehensive benefits to support physical, mental, and financial well-being
- Competitive compensation package
- Annual bonus or long-term incentive opportunities may be offered
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Associate degree
