Manager of Clinical Research Operations

Benefits

Qualifications

• •Registered Nurse License to practice in the state of Florida
• •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
• •8 more items(s)

Responsibilities

• •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
• •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
• •14 more items(s)