Clinical Research Specialist II, CCTO
1 month ago
NOTE: This role is hybrid meaning an onsite presence is required a few days of the week depending on business needs
The Clinical Research Specialist II 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 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, and coordination of departmental research committees.Provides guidance regarding project planning, project logistics, and project implementation.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.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:
Assists in establishing processes and procedures for all Quality Assurance (QA) and QualityControl (QC) functions of the SOCCI Clinical Research Office (CRO) to include industry sponsored studies, investigator-initiated studies, and cancer cooperative group trialsConducts routine and for-cause quality assurance audits or oversees audits of all SOCCI cancer clinical trialsEstablishes effective documentation of audit and monitoring procedures for new and incumbent staffAssists with orientation and training for CRO staff and research faculty as related to research quality measuresWorks within the core to establish efficient and comprehensive procedures for compliance with CSMC IRB and external sponsors for the conduct of routine and regular clinical research, IIT monitoring and auditsUsing a risk based model or equivalent, assists with the identification and/or selection of trials to be reviewed under QMCResponsible for identifying areas concern and/or assesses gaps through routine reviews and may develop process improvements, new policies/work instructions or other documents based on observations through quality management reviews and audits.Lead training seminars, organize webinars or other training/education activities to improve qualityGenerates and maintain quality management records, trackers and applicable reportsDevelops other processes or systems to support quality management coreServes as coordinator for the Data Safety and Monitoring Committee (DSMC) and/or Quality Committees once establishedResponsible for the establishment, documentation, and conduct of real-time safety monitoring for the SOCCI CRO including procedures for eligibility verification, consent verification, comprehensive study start up meetings, timely data collection, and adverse event (AE) and serious AE (SAE) monitoring for investigator -initiated trials
Qualifications
Education and experience requirements:
BA/BS degree.Five (5) years minimum experience in area of research specialty
Req ID : 1259
Working Title : Clinical Research Specialist II, CCTO (Hybrid)
Department : Cancer - SOCCI Clinical Research
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $ $64.02
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