Skip to main content

Regulatory Coordinator I - Smidt Heart Institute - Cheng Lab

Los Angeles, California

Overview

Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. By joining us in an academic role, you’ll be a part of formulating future ideas for discovery and then translating those discoveries into cures for the benefit and health of the Los Angeles community.

Back to Job Navigation (Overview)

Success Profile

What makes a successful Regulatory Coordinator I - Smidt Heart Institute - Cheng Lab at Cedars-Sinai? Check out the traits we’re looking for and see if you have the right mix.

  • Analytical
  • Organized
  • Deadline-oriented
  • Adaptable
  • Results-driven
  • Problem-solver

Back to Job Navigation (Success)

Culture

Discovery is central to Cedars-Sinai’s mission. Our laboratories and clinics generate ideas, therapies, devices, and systems that contribute to biomedical progress around the world. Cedars-Sinai’s investigators push the frontiers of biomedicine with studies in cardiac care, cancer, digestive health, the neurosciences, women’s health, and more. Cedars-Sinai’s robust academic enterprise shapes the experts who will help redefine medicine for the next generation.

Back to Job Navigation (Culture)

Responsibilities

Requisition # 20003512
As a Regulatory Coordinator I, you will prepare and submit protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. You will submit continuations, amendments, responds to questions, generates reports, and maintains files research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties will 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. 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.
  • 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: 
  • Coordinates the administrative and office management system for the department/unit.
  • Maintains calendar of events and tracks deadlines, schedules meetings, makes travel arrangements, submits travel reimbursements. 
  • Prepares and routes internal documents for signature processing.
  • May work with Principal Investigator to complete and submit federal and non-federal grants, including, contributing content to standard sections of grant applications.
  • May work as the liaison between department or research group and sponsored research funds administration, accounting, and finance departments. 
  • May perform all Pre- and Post- grant award administrative functions.
  • May assist in the preparation and submission of documentation required for research compliance. 
  • Assist senior level of research administrators and leadership on other activities as assigned.
Education:
  • BA/BS degree required
Licenses/Certifications:
  • Specialty research certification preferred
Experience:
  • 1-2 years directly related experience
  • Working Title: Regulatory Coordinator I - Smidt Heart Institute - Cheng Lab
  • Department: Heart Institute Operations
  • Business Entity: Academic / Research
  • City: Los Angeles
  • Job Category: Academic/Research
  • Job Specialty: Research Studies/Clinical Trials
  • Position Type: Full-time
  • Shift Length: 8 hour shift
  • Shift Type: Day

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.

Apply Now Apply Later

Rewards

Discover all the ways Cedars-Sinai appreciates your efforts.

  • Healthcare

  • 401(K)/Retirement Plans

  • Continuing Education

  • Relocation Reimbursement

  • Professional Development

  • Work/life Balance

Back to Job Navigation (Rewards)

Sign up for Job Alerts

Join our Talent Network and get Cedars-Sinai news and job alerts delivered to your inbox.

Interested InSearch for a category, location, or category/location pair, select a term from the suggestions, and click "Add".

  • Academic/Research, Los Angeles, California, United StatesRemove

Back to Job Navigation (Job Alerts)