Supv, Clin Research Division - Orlando Health

Leads and supports staff with their clinical research projects. Responsible for conducting and coordinating the involvement of other clinical research coordinators and clinical research associates or data managers in individual research projects.

Essential Functions
• Supervises training and development of other research staff.
• Works with team members in a manner that encourages them to assume ownership of their projects.
• Responds to the needs and priorities established by the Department Director and by the policies and procedures.
• Provides regular updates to the Department Director on the status of studies activities and compliance, including but not limited to data capture, amendments, screening, etc.
• Coordinates clinical research activities and investigations per department requirements.
• Assists with developing and delivering educational sessions related to the management of clinical trials.
• Assesses the conduct and progress of assigned clinical trials by monitoring compliance with protocol and clinical study schedule to ensure protocol compliance.
• Demonstrates the ability to coach research staff and physicians regarding the research process, Code of Federal Regulations and Guidelines for Good Clinical Practice (ICH-GCP).
• Assesses patients for protocol eligibility and communicates findings to investigator/physician.
• Implements protocol procedures. Performs tests, administers drugs and operates specialized equipment as needed in assigned area.
• Assesses and monitors patient responses and adverse reactions; reports same to accountable sources.
• Provides appropriate patient and family education.
• Completes necessary documentation, data capture and submission in an accurate and timely manner.
• Collaborates with physicians and other healthcare staff to ensure adherence to protocol requirements.
• Provides educational in-services as needed.
• Assists in training and development of other research staff.
• Promotes interdepartmental cooperation and coordination for each protocol.
• Functions as a resource person for physicians and staff.
• Manages various personnel functions including hiring, work assignments, coaching plans, and disciplinary actions.
• Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state and local standards.
• Maintains compliance with all Orlando Health policies and procedures.

Other Related Functions
• Participates in the recruitment of research staff.
• Assists in the development and monitoring of the budgetary process as needed.
• Assists in the development of treatment orders for active studies, to be reviewed by the treating physician.
• Assists the research team in preparing for site audits.
• Attends appropriate departmental and/or corporate meetings, study group and/or investigator meetings as required.
• Demonstrates expertise in using computer software specific to department.
• Performs other duties as assigned.

Education/Training
Bachelor degree in a health related field required.

Licensure/Certification
• BLS certification required.
• All RNs and other clinical professionals involved in direct patient care may be required to be licensed by the medical director.

Experience
Four (4) years’ experience in clinical research; or two years management experience in clinical research required.
A master’s degree in related field may substitute for up to two years of the required experience.