Highly qualified candidates, residing in California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia, will be considered for remote work.
Do you have a passion for the highest clinical quality and patient happiness? Would you like to use your expertise with an organization known nationally for excellence in cancer treatment, research and education? We would be happy to hear from you! Please consider the following exciting opportunity with one of the most outstanding and dynamic places to work in the medical field as your next career move.
JOB SUMMARY: The Regulatory Coordinator II 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 insure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, action plans to improve quality, and 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: 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: * Independently responsible for regulatory management for high performing/productive and/or emerging disease research groups (DRG) with moderate to complex research designs and high volumes (i.e. accrual, timelines etc.) * Adheres to critical deadlines and target timelines. * May actively participate in program building within disease research group * May lead assigned project improvement, optimization or enhancements with direct oversight and guidance provided by management team * May participate in or lead other department initiatives as assigned * May provide training, mentorship and/or support to junior staff to ensure adequate regulatory compliance and critically evaluate incoming requests or issues * Serves as liaison for Industry sponsors, clinical coordination/nursing and investigators. * Responsible for ensuring investigator regulatory files and documents are accurate and complete. * Assists in the preparation of and participates in clinical trial educational reviews, monitoring visits (internal or external) and compliance audits. * Provides guidance, under supervision of Manager or designee, to physicians and principal investigators, IBC, CPRMC, PRMC, DSMC, and IRB in the interpretation of applicable regulations and guidelines, to include but not limited to GCP, GLP, ICH, FDA, and NIH OBA guidelines. * Maintains professional growth and development through seminars, workshops, and professional affiliations to keep abreast of latest trends in the field of expertise.
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.