Regulatory Coordinator FT Days- AdventHealth Tampa
Location Address: 3100 East Fletcher Avenue Tampa, Florida 33613
Top Reasons to Work at AdventHealth Tampa
Advent Health Pepin Heart Institute, known across the country for its advances in cardiovascular disease prevention, diagnosis, treatment and research.
Surgical Pioneers – the first in Tampa with the latest robotics in spine surgery
Building a brand new, six story surgical and patient care tower which will ensure state of the art medical and surgical car for generations to come
Awarded the Get With The Guidelines – Stroke GOLD Quality Achievement Award from the American Heart Association/American Stroke Association and have been recognized as a recipient of their Target: Stroke Honor Roll for our expertise in stroke care. We have also received certification by The Joint Commission in collaboration with the American Stroke Association as a Primary Stroke Center.
Work Hours/Shift: FT
Tracks study approvals and expirations to ensure uninterrupted project approval and sponsor and investigator-initiated amendment notifications and submit amended protocols, summaries, and consents to the Institutional Review Board (IRB).
Maintain regulatory electronic document management system & prepares regulatory documents, including consent forms for submission to research review committees.
Maintain and track current Informed consent forms to ensure accurate use by the clinical coordinators.
Submit waiver to the local IRB for trials being overseen by external IRB.
Maintain regulatory binders.
Submits study renewal applications, protocol amendments including ICF and study progress reports to the IRB. Coordinates with study sponsor, investigator, and IRB to complete study closure activities.
Assists with process and policy issues and guides form preparation and submission. Maintains current knowledge of federal and institutional guidelines and requirements governing research.
Recommends and implements regulatory process improvements.
Maintain current documents for research staff, e.g., CVs, licenses, certifications, training, and development of CVs for new personnel
Comply with all standard operating procedures and quality control systems. Attend appropriate professional meetings and review scientific and medical literature to increase research and regulatory knowledge.
KNOWLEDGE AND SKILLS REQUIRED:
Ability to foster communications and teamwork among clinical research faculty, staff, and external organizations (sponsors and contract research organizations).
Excellent written, oral and conversational communication skills to effectively work with diverse groups.
Ability to analyze, evaluate multiple solutions and solve complex problems using well developed critical and analytical thinking skills.
Excellent time management skills & Prioritize.
Attention to detail.
Proficient in Microsoft Office, especially Word and Excel, multiple electronic databases and computer-based information systems, including eIRB
Knowledge and understanding of clinical research, including comprehensive knowledge of FDA guidelines.
EDUCATION AND EXPERIENCE REQUIRED:
Bachelor’s degree in a health-related field
Related experience demonstrating the appropriate competencies and skills for the job and clinical setting.
Research experience including awareness of FDA / OHRP / ICH / GCP Guidelines and relevant state and federal regulatory/statutory guidelines.
A minimum of two years documented regulatory experience in healthcare or equivalent
Records management experience
LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:
At AdventHealth, Extending the Healing Ministry of Christ is our mission. It calls us to be His hands and feet in helping people feel whole. Our story is one of hope — one that strives to heal and restore the body, mind and spirit. Our more than 80,000 skilled and compassionate caregivers in hospitals, physician practices, outpatient clinics, urgent care centers, skilled nursing facilities, home health agencies and hospice centers are committed to providing individualized, wholistic care.