Cedars-Sinai Cancer is committed to pursuing pioneering research into disease mechanism, diagnostic innovations and new technologies and resources. Through our historic achievements, growing research enterprise, and serving one of the most diverse regions in the world, our physicians and scientists are uniquely positioned to guide the next generation of progress against the disease.
Join our team and use your expertise with an organization known nationally for excellence in cancer research.
The Clinical Research Specialist I - Sponsor Investigator Support Unit provides clinical research expertise by participating in the development and implementation of research program. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Provides administrative protocol review to ensure language is consistent with regulatory obligations and helps ensure consistency throughout protocol. Responsible for protocol formatting and version control.
In addition, the CRS I- SPIN will be responsible for the following:
Work with CRO management to develop processes for investigator initiated trials including: developing process workflows, manuals, standard protocol language, forms, worksheets, instructions and tools, establishing template and guidance documents. May also provide input or help develop training materials for staff and/or investigators.
Assists in protocol writing for standard CRO sections of the protocol and may develop standard language as appropriate
Supports investigators with all FDA correspondence to ensure compliance with federal regulations for institutionally/PI held IND/IDEs
Facilitates protocol development and start-up process through parallel work streams and various cores
Responsible for assisting PI in protocol registration for clinicaltrials.gov and clinical trials reporting program (CTRP) and results posting to applicable sites for IITs
Maintains appropriate trackers, generates routine and ad-hoc reports and provides project management support to ensure timely protocol development and activation and portfolio management
Serves as central point of contact and works with cross-functional team members (i.e. biostatistics, research informatics etc) to ensure sound protocol and logistic set up
May provide regulatory support for IIT/IIS such as IRB submissions, regulatory documents, continuing reviews and ongoing binder maintenance and respond to QA findings by providing corrective/preventative action plans, training, instituting new processes or equivalent
Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees.
May provide fiscal management (i.e. budgeting, accounting, cost projections) for assigned IIT/IISs
This position is eligible for the Employee Referral Program. See website for details: http://careers.cedars-sinai.edu/working-here/employee-referrals/
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 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.