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Regulatory Coordinator I - Cancer Clinical Trials Office

Requisition # 19000564 Apply Now

The Regulatory Coordinator I 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 files 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. 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 Functions:

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:

Provide regulatory support for new and ongoing research studies. Includes but not limited to correspondence with institutional and federal regulators and study file documentation creation and maintenance.

Ensure compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.

Organize and store protocol files including but are not limited to: all protocol submission documents, correspondence from sponsor and study team, and responses/re-submissions.

Assist in maintenance of regulatory-related internal tracking databases and filing systems. Assist in compilation of regulatory-related metrics for use by senior management.

Participates in the pre-pending study management process including Confidentiality Disclosure Agreements (CDAs) and Feasibility Questionnaires (FQs).

May attend Disease Research Group (DRG) meetings.

Communication with study staff to ensure the maintenance and accuracy of the Delegation of Duties and Authority Log (DOAL). Ensure in conjunction with the DOAL that all subsequent training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder.

Ensure all necessary forms are submitted to the trial sponsor and the IRB. Other duties as assigned by senior management.

 

Educational Requirements:

Bachelor’s degree required

 

License/Certification Requirements:

Specialty certification preferred

 

Experience:

One (1) year directly related experience

 

Physical Demands:

Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.

  • Working Title: Regulatory Coordinator I - Cancer Clinical Trials Office
  • Department: SOCCI Clinical Research Office
  • Business Entity: Academic / Research
  • City: Beverly Hills
  • Job Category: Compliance/Quality
  • Job Specialty: Research Compliance
  • Position Type: Full-time
  • Shift Length: 8 hour shift
  • Shift Type: Day
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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). 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 March each year) as a condition of employment, and annually thereafter as a condition of continued employment.

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