Regulatory Coordinator III - Translational Research Concierge
Requisition # HRC0551957
Contact Interim Associate Director Grant Dagliyan at email@example.com with any questions.
At Cedars-Sinai, we're motivated by a collective spirit of innovation and the challenge to continuously improve. Above all, we share a real passion for helping others. This is just one of the many reasons U.S. News & World Report has named us one of America’s Best Hospitals—and now we invite you to join us and make a difference every single day in service of this outstanding work – excellence and innovation in patient care, research, and community service. From working with a team of committed professionals to using state-of-the-art facilities, you’ll have great resources to do something incredible—for yourself, and for others!
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, participating in 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 Responsibilities
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.
Ability to identify areas of project interest and interact with appropriate support group: SPIN, IRB, Tech Transfer
Completes forms and generates all reports required 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 research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
May participate in internal auditing of regulatory documents.
May supervise Regulatory Coordinator I/II and/or 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.
Establishes and continuously assesses the efficiency of the internal controls within the unit and compliance with organizational policies and procedures.
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 Specific Responsibilities
The Regulatory Coordinator III will be responsible for the oversight and coordination of regulatory aspects for all projects that are managed by the Translational Research Concierge (TRC) group. Responsibilities include independently managing and preparing submissions of new studies, modifications, renewals, adverse events, and study closures to the IRB, FDA and other ancillary committees including, Protocol Review and Monitoring Committee (PRMC). The RAC III helps with effectively steering protocols through the regulatory committee process in a timely manner to ensure a prompt activation of trials and for all regulatory aspects of the protocols assigned. In addition, the RAC III serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to pharmaceutical companies, and other research entities. The incumbent must accurately maintain regulatory information in the clinical trial management system (OnCore).
Ability to work with deadline driven structure and demonstrated experience in maintaining flexibility and adaptability while implementing institutional change. Ability to take initiative and demonstrate strong commitment to duties with a high level of integrity in compliance with regulatory management
Develop Standard Operating Procedures for the TRC support group.
Bachelor's Degree, minimum.
Certification of Clinical Research Professional, preferred.
Five (5) years of directly related experience, minimum.
Working Title: Regulatory Coordinator III - Translational Research Concierge
Department: Cancer Institute
Business Entity: Academic / Research
City: West Hollywood
Job Category: Family & Function, Academic / Research
Job Specialty: UNASSIGNED
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). 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.