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Clinical Research Specialist I - Protocol Review and Management System (PRMS)

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Requisition # HRC0523726

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 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:

  • 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.

Department and/or Unit Specific – Essential Job Responsibilities:

The Clinical Research Specialist 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 CCTO. The department essential job responsibilities include:

  1. Provides project management support by coordinating meetings and materials for the Protocol Review and Monitoring Committee (PRMC) and Data Safety Monitoring Committee (DSMC) and Clinical Research Leadership Committee (CRLC) meetings to ensure the committees function within the limits of the applicable charter and that protocols are reviewed timely and correspondences 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, DSMC, and CRLC 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 Committee members, in collaboration with the Committee Chairs.
  8. Works with CCTO management to establishes and optimizes metric reports.
  9. Work with CCTO managers to develop Standard Operating Procedures or Working Instructions for the CCTO in accordance with federal and local requirements.
  10. Develop and lead educational efforts at SOCCI.
  11. Lead and/or coordinate other CCTO projects as needed.

Educational Requirements:

  • BA/BS degree.

License/Certification:

  • ACRP/SoCRA (or equivalent) certification preferred.

Experience:

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

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 - Protocol Review and Management System (PRMS)
  • Department: SOCCI Clinical Research Office
  • Business Entity: Academic / Research
  • City: Los Angeles
  • Job Category: Academic/Research
  • Job Specialty: Research Studies/Clinical Trials
  • Position Type: Full-time
  • Shift Length: 8 hour shift
  • Shift Type: Day

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. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.

At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through March each year) as a condition of employment, and annually thereafter as a condition of continued employment.

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