Cedars-Sinai Clinical Research Specialist I - Cancer Clinical Trials Office in Los Angeles, California
The Cancer Clinical Trials Office (CCTO) staffed by highly trained professional research staff (research nurses, clinical research coordinators, and clinical research associates), is a central office that provides the infrastructure and function for operations of Cancer Clinical Trials at Cedars-Sinai Cancer, including its medical network and health system, which at any given time has approximately 140 cancer clinical trials. CCTO resources are available to both faculty and industry sponsors to assist throughout the lifecycle of a protocol, from inception to study closeout. We coordinate with investigational pharmacy, laboratory, nursing, the National Cancer Institute (NCI) and other collaborating academic institutions.
Join our team and use your knowledge with an organization known nationally for excellence in cancer research!
The Clinical Research Specialist I provides clinical research guidance 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).
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.
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.
Work with CRO management to develop process 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.
May provide fiscal management (i.e. budgeting, accounting, cost projections) for assigned IIT/IISs.
- BA/BS degree, required.
- ACRP/SoCRA (or equivalent) certification preferred.
- Three (3) years minimum experience in area of research specialty.
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.