The Clinical Research Specialist I - Committees Coordinator is responsible for efficient management of the SOCCI Protocol Review and Management System (PRMS) and Data Safety Monitoring Committee as well as other major projects that are needed to support the CRO. The Clinical Research Specialist I 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).
1) Provides project management support by coordinating meetings and materials for the Protocol Review and Monitoring Committee (PRMC) and Data Safety Monitoring Committee (DSMC) meetings and ensures the committees function within the limits of the applicable charter and that protocols are reviewed timely and correspondence is returned to investigators timely.
2) Reviews all applications to the PRMS and DSMC to ensure accuracy and completeness. Identifies the need for any ad-hoc members and works with the Chair to assign reviewers.
3) Serves as the primary point of contact for PRMS and DSMC inquiries and provides technical support for investigators and staff
4) Maintains all PRMS and DSMC required documentation and manages tracking in the applicable systems
5) Assists in implementing modifications to the committee charters, establishment of processes, training materials or committee documentation and identifies opportunities to better meet the National Cancer Institute (NCI) criteria for feasibility and scientific review of protocols and ongoing data safety and protocol monitoring.
6) Conducts initial assessment to classify research protocols per the NCI categories and determine PRMS review scope
7) Onboards and trains new PRMC members
8) Works with CRO management to establishes and optimizes metric reports
9) Work with CRO managers to develop Standard Operating Procedures or Working Instructions for the CRO in accordance with federal and local requirements
10) Develop and lead educational efforts at SOCCI
11) Lead and/or coordinate other CRO projects as needed
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 rese...arch 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.