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 team meetings, and working with 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).

Job duties and responsibilities:

• Submits continuations and amendments as vital 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.
• 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.
• Participate in weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
• 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.
• 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.
• 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 mentorship 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, supervising 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 stay on top of the latest trends in the field of expertise.

Educational Requirements

• BA/BS degree.
• ACRP/SoCRA/RAPs (or equivalent) certification preferred.

Experience:

• Three (3) years minimum of directly related experience, or equivalent combination of education and experience.

Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.

At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu) and COVID-19. For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines such as COVID-19 as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.

Three (3) years minimum of directly related experience, or equivalent combination of education and experience.