The Clinical Research Specialist I - Sponsor Investigator Support Unit provides clinical research expertise by participating in the design and implementation of research projects as needed. 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. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
DEPARTMENT AND/OR UNIT SPECIFIC - ESSENTIAL JOB RESPONSIBILITIES:
* 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.
* 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.
* 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 Quality Assurance (QA) findings by providing corrective/preventative action plans, training, instituting new processes or equivalent
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution.
Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
Coordinates research projects at an institutional or departmental level.
Communicates project status and improvement areas with leadership in a timely manner.
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 implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.
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.
Participates in required training and education programs.
May provide fiscal management (i.e. budgeting, accounting, cost projections) for assigned IIT/IISs
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.