The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. We are committed to bringing innovative therapeutic options to all of our patients with cancer. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care.
The Angeles Clinic is looking for a Senior Regulatory Coordinator who will prepare and submit moderately complex protocols and supporting documentation to regulatory bodies and research committees involved in the pre-award and post-award process. This role submits the continuations, amendments to regulatory bodies and responds to a broad range of questions. Generates reports and maintains files and documentation for compliance with regulatory requirements (federal and local agencies, including the Food and Drug Administration and Local Institutional Review Board) for the assigned study and/or clinical trial.
Submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices.
Completes forms and generates reports from multiple data sources to comply with the assigned protocals for the study and/or clinical trail.
Maintains research files and may audit documentation pertaining to regulatory requirements for clinical trails.
Responds to generally broad data requests and questions.
Monitors the status of assigned regulatory submissions and amendments from end-to-end.
Partners with research staff and investigators to ensure that all regulatory documents for the assigned research studies are up to date.
Represents the unit in cross functional meetings and provides updates on the status of assigned regulatory submissions.
Supports the unit in internal and external auditing of regulatory documents.
Identifies quality and performance improvement opportunities to support efficient workflows.
Maintains strict patient confidentiality according to HIPAA regulations and follows guidance according to applicable law, research practices using Good Clinical Practice (GCP) guidelines.
3 years Regulatory support experience, required
Bachelor's Degree, required
Working Title: Senior Regulatory Coordinator - The Angeles Clinic and Research Institute
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.