The Regulatory Coordinator III will provide supervision of other regulatory staff. Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. This role submits continuations, amendments, responds to questions, generates reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the medical center when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to ensure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, action plans to improve quality, or training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Provides supervision of other regulatory staff.
Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC.
Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study.
Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
Meets with monitors from pharmaceutical companies and represents the medical center during these meetings.
Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
May provide training and education of other personnel.
May participate in centralized activities of the department or institution.
May plan and coordinate strategies to improve existing standard operating procedures related to regulatory affairs.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
May be required to develop clinical trial budgets.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
DEPARTMENT AND/OR UNIT SPECIFIC – ESSENTIAL JOB RESPONSIBILITIES:
Coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) including communicating with ancillary committees, study team, contract research organizations, and sponsors.
Assist with training of all regulatory personnel with regards to regulatory compliance.
Act as a mentor for new employees and find ways to improve the department's mentorship program.
Work directly with senior management to examine opportunities for regulatory innovation and promote the use of novel approaches within the project team to resolve issues and problems.
Conduct regular quality review on enrolling studies on an on-going basis
Maintain of regulatory-related internal tracking databases and distribute evenly regulatory tasks within the assigned team.
Compile regulatory-related metrics for use by senior management.
Assist in the development of written work instructions and conducts training opportunities.
Communicate to study research personnel and investigators relevant changes to regulatory processes.
Participate in the audit response and CAPA processes to identify, recommend, and implement corrective and preventive actions for regulatory and other related processes with the guidance of senior leadership.
Verify that implemented corrective and preventive actions are suitable and effective by supporting implemented quality assurance (QA) & quality control (QC) checks on active clinical trials.
Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards in quality and innovation in patient care, research, teaching and community service. Today, Cedars-Sinai is widely known for its national leadership in transforming healthcare for the benefit of patients.Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S. with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Clinical programs range from primary care for preventing, diagnosing and treating common conditions to specialized treatments for rare, complex and advanced illnesses. In addition, Cedars-Sinai serves the community through its Medical Network, which includes the highly rated Cedars-Sinai Medical Group and Cedars-Sinai Health Associates. Cedars-Sinai has consistently been named one of America’s Best Hospitals by U.S. News & World Report, has received the National Research Corporation’s Consumer Choice Award 18 years in a row for providing the highest quality medical care in Los Angeles, and has the longest running Magnet desig...nation for nursing excellence in California. Cedars-Sinai is a leader in the clinical care and research of heart disease, cancer and brain disorders, among other areas. Pioneering research achievements include using cardiac stem cells to repair damaged hearts, developing minimally invasive surgical techniques and discovering new types of drugs to target cancer more precisely. Cedars-Sinai also impacts the future of healthcare through education programs that encompass everything from highly competitive medical residency and fellowship programs to a biomedical science and translational medicine PhD program, advanced training for nurses and educational opportunities for allied health professionals. Most notably, Cedars-Sinai demonstrates a longstanding commitment to strengthening the Los Angeles community through wide-ranging programs that improve the health of its most vulnerable residents.