Supervisor, Research Regulatory Coordinator - Orlando Health Cancer Institute

Orlando Health•Orlando, FL

About The Position

As a top cancer care provider in Florida, Orlando Health Cancer Institute is a comprehensive, multidisciplinary cancer program consisting of six treatment sites and more than 10 practice locations that serve the region’s adult oncology needs. Specializing in more than 200 types of cancer, an expert team of medical professionals provides personalized care with the most state-of-the-art technologies, such as advanced radiation and proton therapies, and bone marrow transplant and cellular therapy. Through a robust research program, the institute also supports physician involvement in numerous research studies and clinical trials that give patients access to innovative diagnosis, treatment and symptom management options. In addition to being accredited by the Commission on Cancer, a program of the American College of Surgeons, Orlando Health Cancer Institute has earned accreditations and certifications in several areas — including medical oncology and hematology/oncology, radiation oncology, cellular therapy, rectal cancer, and breast care — from the respective accrediting organizations, and recently was named in the 2023 Becker's Hospital Review “60 Hospitals and Health Systems with Great Oncology Programs” list. Orlando Health Cancer Institute is part of the Orlando Health system of care, which includes 24 award-winning hospitals and ERs, 9 specialty institutes, 14 urgent care centers, 100+ primary care practices and more than 60 outpatient facilities that span Florida’s east to west coasts and beyond. Collectively, we honor our 100-year legacy by providing care for more than 142,000 inpatient and 3.9 million outpatient visits each year. Orlando Health is committed to providing you with benefits that go beyond the expected, with career-growing FREE education programs and well-being services to support you and your family through every stage of life. We begin your benefits on day one and offer flexibility wherever poss. Responsible for supervising and for coordinating the involvement of the Research Regulatory Coordinators in individual research projects.

Requirements

Bachelor’s degree.
Associate’s degree and two (2) years of directly related work experience may substitute for the Bachelor’s degree (in addition to the requirements listed in the Experience section).
Maintains current Certified Clinical Research Professional (SoCRA) OR Certified IRB Professional (PRIM&R), OR Certified Clinical Research Coordinator (ACRP).

Responsibilities

Supervises the coordination of the protocol review and approval process, to include submissions to regulatory agencies.
Develops and delivers 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 safety of human subjects.
Acts as a resource in exceptional situations requiring immediate intervention as deemed necessary.
Develops and trains all research staff and physicians regarding the research process, Code of Federal Regulations and Guidelines for Good Clinical Practice (ICH-GCP).
Audits clinical research.
Maintains, develops and implements standard operating procedures.
Ensures accurate and timely completion of clinical research regulatory processes.
Coordinates activities of team members on other shifts to ensure continuity of services as deemed necessary.
Serves as an ambassador of the Clinical Research Director, the Department and the Institution through relationships with outside collaborations (industry, cooperative groups and professional societies).
Reviews clinical research documents to determine compliance with policies, procedures, objectives, quality assurance, and good clinical practices.
Provides follow up with required action for protocol amendments, deviations, severe adverse events, re-consent process, patient accrual logs, etc.
Works with team members in a manner that encourages them to assume ownership of their projects.
Provides comprehensive, regular updates to the department Director on the status of studies activities and compliance.
Communicates cooperatively and constructively with physicians, physicians’ office team members, guests, and members of the healthcare team. Demonstrates excellent verbal and written communication skills.
Responsible for the orientation, training and skill development of new team members.
Manages various human resources functions including hiring, work assignments, coaching plans, and performance counseling.
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.
Maintains required records, reports and files.
Maintains Institutional Review Board submission and reception of documents.
Assists the department Manager in developing and updating job descriptions, core competencies, and orientation programs.
Works independently with minimal supervision.
Assume the responsibility for professional growth and development.
Attends training programs and community meetings and activities; when required facilitates such meetings.
Participates with the team in program planning and development, defining and implementing programmatic objectives, procedures and policies, and ensuring the continuous improvement of services.