Clinical Research Specialist - Data Safety Monitoring Committee (DSMC) - Cancer Clinical Trials Office

The Cancer Clinical Trials Office (CCTO) staffed by highly trained professional research personnel (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 are the central point of contact who coordinates with investigational pharmacy, laboratory, nursing, the National Cancer Institute (NCI) and other collaborating academic institutions.Join our team and use your expertise with an organization known nationally for excellence in cancer research.The Clinical Research Specialist I is responsible for efficient management of the Data Safety Monitoring Committee as well as other major projects that are needed to support the CCTO. The department essential job responsibilities include: 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). 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. 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. Serves as the primary point of contact for DSMC inquiries and provides technical support for investigators and staff.Additional job duties and responsibilities:Maintains all DSMC required documentation and ensures accurate recording of DSMC reviews into the clinical trial management system (OnCore).

Attends all DSMC committee meetings, ensuring procedures are followed and that minutes of committee meetings are taken, reviewed, and stored in an organized manner.

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.

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.

Onboards and trains new DSMC members

Works with CCTO management to establish and optimize metric reports.

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.

Co-authors committee decisions on responses to investigators, assures these are reviewed, signed by the DSMC Chair, and communicated promptly to the investigator.

Communicates in a timely manner with Leadership regarding significant or time sensitive issues that arise that my hinder processing of reviews.

Assists in management of SOCCI Protocol Review and Management Committee by serving as a backup when necessary.

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.

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.

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.

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.

Performs other related duties as assigned or directed by Leadership to meet the goals and objectives of the CCTO.

Experience:Three (3) years minimum experience in area of research specialty.

Prior monitoring or auditing experience in clinical research preferred.

Strong knowledge of federal, state, and local regulations regarding the conduct of clinical trials, the informed consent process, and protection of human subjects.

Education:Minimum of BA/BS degree, required

Licenses/Certifications:Certification through a professional organization such as Regulatory Affairs Professional Society (RAPS, The Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP), preferred.

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.