The Cancer Clinical Trials Office (CCTO) staffed by highly trained professional research personnel (research nurses, clinical research coordinators and clinical research associates), is a central office that provides the infrastructure and function for operations of Cancer Clinical Trials at Cedars-Sinai Cancer, including its medical network and health system, which at any given time has approximately 140 cancer clinical trials. CCTO resources are available to both faculty and industry sponsors to assist throughout the lifecycle of a protocol, from inception to study closeout. We are the central point of contact who coordinates with investigational pharmacy, laboratory, nursing, the National Cancer Institute (NCI) and other collaborating academic institutions.
Join our team and use your expertise with an organization known nationally for excellence in cancer research.
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:
In collaboration with the manager, responsible for performing staff recruitment, screening, interviewing, hiring, performance evaluations, and counseling activities for the Unit.
Assist in the development of goals for direct reports to foster professional growth and complete annual performance reviews following the Human Resource (HR) procedures. In addition, routinely monitor and evaluate staff performance during the annual review period and provide constructive and meaningful assessments on their performance.
Monitor regulatory staff workload intensity and track deadlines to ensure timely submission and/or completion and appropriate regulatory reporting and compliance. Promote design, development, implementation, and assessment of sustainable workflows/solutions that will support the compliant conduct of clinical trials.
Contribute to the review of new studies and provide guidance relevant to study start-up, activation, management, and close-out requirements. Serve as the primary resource for Investigators and clinical research team on regulatory matters, including collaborating departments and external partners.
Collaborate with senior clinical management teams to support audit-related activities and written responses, in addition to developing, implementing, and monitoring Corrective and Preventive Action Plans (CAPA).
Facilitate and promote the ongoing improvement of clinical trial compliance and quality assurance through the communication of audit results and providing supplemental regulatory training. Resolve regulatory queries through close collaboration with auditors, monitors, Investigators, research personnel, and partners.
Collaborates with scientific and clinical faculty, managers and sponsor representatives, other departments, vendors, regulatory agencies and staff in development of new processes, problem-solving and conflict resolution. Leverage technology, in collaboration with research senior leadership, to promote compliance, increase efficiency, and improve effectiveness by recommending, implementing, integrating, and/or optimizing electronic systems, software, and solutions.
Kronos editing/Time off requests
Lead bi-weekly regulatory meeting with Reg Core.
Coordinate the process of regulatory document submission to the Institutional Review Board (IRB) including communicating with ancillary committees, study team, contract research organizations, and sponsors.
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.
Maintainenance of regulatory-related internal tracking databases and distribute evenly regulatory tasks within the assigned team.
Compile regulatory-related metrics for use by senior management.
Communicate to Program Managers, study research personnel and investigators relevant changes to regulatory processes.
Other duties as assigned by senior management.
Additional 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.
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.