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Cancer Specialists of North Florida · 10 hours ago

Clinical Research Manager

Jacksonville, FL

Full-time

Onsite

Senior Level

7+ years exp

Cancer Specialists of North Florida is recruiting for an experienced Clinical Research Manager for their busy practice. The Research Clinical Manager is responsible for the coordination of all research activities throughout the organization, managing clinical trials, and ensuring compliance with regulatory requirements.

Health CareOncology

Responsibilities

Obtain and review trials for participation upon research committee’s approval; initiates study protocol by oversight of required regulatory documents submission

Responsible for oversight of research business operations including; departmental budgets, financial planning and tracking infrastructures, as well as protocol specific budgetary and contractual negotiations with pharmaceutical companies

Coordinates payment of provided study procedures and ensures accurate data collection in a timely manner to the sponsor

Maintains protocol regulatory documents for compliance with Institutional Review Board, including renewal, amendments and submissions of new protocols

Oversees clinical operations for research department including drug accountability, storage & handling and proper mixing procedures

Maintains a sound plan for organization and recommends changes as needed due to growth and development of the research department

Holds and coordinates training for research personnel for a maximum service to patients in accordance with policies and procedures

Acts as a resource for clinical staff and patients regarding questions of protocol studies

Reports protocol activities, monthly accrual reports at meetings

Promotes and educate clinical staff on the protocol studies available to patient enrollment

Develops and establishment of policies and procedures. Ensures their adequate execution, compliance and updates

Ensures all research activities are carried out in compliance with organizational policies, procedures, and governmental laws and regulations

Maintains strict patient confidentiality at all times

Special projects as assigned

Qualification

Oncology experienceClinical trial managementRegulatory complianceBudget managementClinical documentationBLCS certificationSOCRA certificationManagement experienceTraining coordinationPatient confidentiality