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Cedars-Sinai Regulatory Coordinator II - Clinical Research - Department of Medicine in Los Angeles, California
When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.
The Regulatory Coordinator II in the Department of Medicine completes all regulatory documents and applications in order to start up new clinical trials. 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. 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).
Primary 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.
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.
- Bachelor of Arts or Sciences degree, required.
- Specialty research certification, preferred.
Experience and Skillset:
- Three (3) years minimum of directly related 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.