Regulatory Coordinator II - Heart Institute - Makkar Lab

Cedars-Sinai functions as a nonprofit academic healthcare institution that caters to the diverse Los Angeles community and beyond. We are one of the leading institutes for competitive research funding from the National Institutes of Health. As an international leader in biomedical research, we translate discoveries into successful treatments with global impact. Cedars-Sinai is a hub for biomedical research with discoveries occurring in 26 departments and institutes that encompass the full spectrum of medicine.

The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes. 

Why work here?

Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for.

The Regulatory Coordinator II prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS, Cedars-Sinai IRB, External IRB, IACUC and any research committee involved in the Pre-Award/Post-award process. 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 Research Department when meeting with sponsors, attending 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, 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 Duties and Responsibilities:

• Prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS (if needed), Cedars-Sinai IRB, External IRB, IACUC and any research committee involved in Pre/Post-award process.
• 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 research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
• Participates in required training and education programs and 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 including drafting SOP’s and/or job aids.
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• 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.

Qualifications:

• Bachelor's degree required.
• Three (3) years minimum of directly related Regulatory experience.
• Licenses/Certifications: Specialty research certification preferred.