Job Posting: The Clinical Research Office (CRO) of the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai has overall responsibility for the performance of cancer trials and other cancer research studies. The CRO provides support and services to faculty and staff conducting oncology research. This includes coordination of staff support, provision of centralized systems, regulatory expertise, and quality assurance. The regulatory affairs office, specifically, is comprised of a core group of experts who support cancer center members, across all disease research groups, facilitate high quality research by facilitating overall study start-up, maintenance, close-out and provides guidance to ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB) and Good Clinical Practice (GCP). The regulatory affairs office submits new protocols, continuations, amendments to local IRB, responds to questions, generates reports, and maintains research files and documentation (i.e. FDA form 1572, financial disclosures, delegation of authority) 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. The regulatory core provides support for industry, grant funded and investigator initiated research. Objectives of the Regulatory Affairs (Clinical Research) Internship:
Gain valuable work experience in the healthcare industry while working with regulatory professionals on various projects;
Learn about the role of regulatory affairs in an academic setting, specifically in human subjects, as well as the regulatory landscape;
Receive on the job training;
Be assigned a mentor;
Develop a well-rounded skill set through assignments;
Gain familiarity and exposure to Oncology therapeutic areas;
Create a personalized growth plan to serve as a step-by-step guide towards the experiences, knowledge and resources necessary to achieve your career goals and receive training customized to support your individual growth and development;
Rotate through three one-year challenging, demanding and diverse Regulatory Affairs assignment;
Learn about the study protocol which details how the study is designed, the methodology, how participants are chosen, the mechanism for data collection and data confidentiality. Candidate will also participate in online training on Responsible Conduct of Research. Primary Duties: The main duties of the Regulatory Affairs intern is to support an assigned clinical research portfolio through IRB/FDA correspondence (new study activation, amendments, continuing reviews, safety reporting), informed consent development, regulatory document generation and maintenance, attend routine disease research group meetings, facilitate external monitoring visits for industry research, May participate in special projects as assigned. The intern will be partnered with a mentor to ensure the experience is rich and personal and complete a rotation (round/job shadow) with key clinical research positions. A regulatory affairs manager will oversee day-to-day activity and provide guidance and training. This position will not interact with human subjects. EEO / AA / F / M / Veteran / Disabled Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
Qualified candidates must be interested in continuing careers in Regulatory Affairs;
Possess the minimum of a Bachelors in Life Science (ie Biology, Chemistry, Immunology, Medical Technology, Pharmacy, Pharmacology, Microbiology), policy/administration, public health, life science, pharmacy, medicine, or related discipline.
Must be eligible to work in the U.S;
Strong academic performance and extra curricular achievement, GPA 3.0 or higher, preferred;
Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation, initiative, integrity and professional maturity;
Able to perform in a fast paced challenging environment;
Demonstrate basic knowledge of governing regulations and good clinical practice (GCP);
Good oral and written communication skills;
Passion to succeed;
Previous research and analysis work experience will be given preference. Final candidate should successfully complete pre-employment process and attend a 2-day New Employee Orientation Physical Demands: (e.g., lifting, standing, walking) 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.
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-scien...tists 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 teaching 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.