The Clinical Research Specialist 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).
Essential job Duties and Responsibilities:
Provides clinical research expertise by participating in the design and implementation of research projects and care of research patients 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.
Implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.
Provides guidance regarding project planning, project logistics, and project implementation
Serves as an internal consultant for specific departmental activities.
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.
Provides clinical expertise and support with quality assurance, performance improvement, and health plan compliance for clinical trial compliance.
Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according FDA, HSPC, HIPAA an d other agency guidelines.
Responsible for insuring timely submission of complete, accurate and neat documents to research sponsors, IRB, and contract research organizations, where applicable.
Participates in weekly research staff meetings.
Acts as a liaison with Principal Investigators, pharmaceutical company representatives and other project funding organizations to monitor and update project progress.
Prepares for institutional, pharmaceutical and internal audits, including facilitating third party study monitoring.
Attends site feasibility visits and site initiation visits for potential studies, and assures that new studies are implemented according to protocol.
Review pertinent medical records to determine opportunities for quality improvement. Analyze quality metric data in support of the Principal Investigator and Director of Clinical Services.
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.