Clinical Research Specialist I - Clinical Research Office

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The Clinical Research Specialist I provides clinical research expertise by participating in the design and implementation of research projects as needed. The incumbent is responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. The team member in this role may implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts, and ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties And Responsibilities

• Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• 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.
• Coordinates research projects at an institutional or departmental level.

Department-Specific Responsibilities

• Onboards and trains new DSMC members.
• Independently prioritizes workload and performs a comprehensive review of all cancer related clinical research study monitoring, audit and safety reports and responses to be reviewed by the DSMC, within the appropriate timelines, and implements the operations of the DSMC.
• Attends all DSMC committee meetings, ensuring procedures are followed and that minutes of committee meetings are taken, reviewed, and stored in an organized manner.
• Communicates in a timely manner with Leadership regarding significant or time sensitive issues that arise that my hinder processing of reviews.
• Works with CCTO management to establish and optimize metric reports.
• Ensures meeting materials (e.g., SAE reports, protocol deviation reports, etc) are organized with the goal of enhancing review of information by the committee and aid in decision making.
• Assist in the management of the day-to-day operations and system applications associated with Clinical Trial Reporting Program (CTRP), including registering required CCTO trials in CTRP and abstracting relevant information from protocol and CTMS for submission to the CTRP Registration Site.
• Regularly evaluates DSMC process for areas of inefficiency, and works with CCTO management to propose and implement changes for improving processes, and upon approval incorporates changes into the SOP and Charter.
• Incorporates knowledge of the principles of clinical trials conduct, in order to assess the readiness of research protocol reports and other review documents for review by the DSMC. Identifies the need for any ad-hoc members and works with the Chair to assign reviewers.
• Co-authors committee decisions on responses to investigators, assures these are reviewed, signed by the DSMC Chair, and communicated promptly to the investigator.
• Finds opportunities to better meet the National Cancer Institute (NCI) criteria for feasibility and scientific review of protocols and ongoing data safety and protocol monitoring.
• Assists with quarterly reporting of minimum elements of patient accrual information (for Complete and Abbreviated trials) either via the CTRP Accrual Registration Web Site; or Accrual Batch file submission.
• Maintains all DSMC required documentation and ensures accurate recording of DSMC reviews into the clinical trial management system (OnCore).
• Performs other related duties as assigned or directed by Leadership to meet the goals and objectives of the CCTO.
• Serves as the primary point of contact for DSMC inquiries and provides technical support for investigators and staff.
• Works closely with PIs and study teams, and monitor CTMS data entries, to assure that all applicable trials are registered on the CTRP Registration as required by NCI policies.
• The Clinical Research Specialist is responsible for efficient management of the SOCCI Data Safety Monitoring Committee as well as other major projects that are needed to support the CCTO.
• Verifies and troubleshoots protocol web summaries (Trial Summary Report, TSR and xml file) as developed by CTRP, and maintain the CTRP electronic protocol listing. This function requires understanding of CTRP reports in light of submitted trial information.
• Assists in management of SOCCI Protocol Review and Management Committee by serving as a backup when necessary.
• Provides project management support by coordinating meetings and materials primarily for the Data Safety Monitoring Committee (DSMC) meetings and secondarily to the Protocol Review and Monitoring Committee (PRMC).
• Assists in implementing modifications to the committee charters, establishment of processes, training materials or committee documentation.

Education
Bachelor's degree (BA or BS) is required.
Licenses/Certifications
Certification through a professional organization such as Regulatory Affairs Professional Society (RAPS) or The Society of Clinical Research Associates (SOCRA) preferred.
Experience

• 3 years of related experience in a similar position is required.
• Strong knowledge of federal, state, and local regulations regarding the conduct of clinical trials, the informed consent process, and protection of human subjects.
• Prior monitoring or auditing experience in clinical research preferred.

Physical Demands
Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
Working Title: Clinical Research Specialist I - Clinical Research Office
Department: SOCCI Clinical Research Office
Business Entity: Cedars-Sinai Medical Center
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$64,800.00 - $110,000.00