The Clinical Research Specialist I - Quality Management Core assists in establishing processes and procedures for all Quality Assurance (QA) and Quality Control (QC) functions of the SOCCI Cancer Clinical Trials Office (CCTO) to include industry sponsored studies, investigator-initiated studies, and cancer cooperative group trials. Conducts routine and for-cause quality assurance audits or oversees audits of all SOCCI cancer clinical trials. Works within the core and with colleagues outside 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 audits.
In addition, the Clinical Research Specialist I- QMC will also responsible for the following:
Establishes effective documentation of audit and monitoring procedures for new and incumbent staff
Assists with orientation and training for CCTO staff and research faculty as related to research quality measures
Using a risk based model or equivalent, assists with the identification and/or selection of trials to be reviewed under QMC
Responsible for identifying and reporting to her supervisor and leadership as needed, areas of 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 quality
May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.
Generates and maintain quality management records, trackers and applicable reports
Develops other processes or systems to support quality management core
Work as a specialist in the SOCCI CCTO Quality Management Core, as a Quality Assurance Monitor by conducting reviews in the following categories:Audit Preparations (APs), Internal /Educational Reviews (IERs), Investigator-Initiated Trial Monitoring Reviews (IITMRs), Eligibility Verifications (EVs), Track the reviews and visits and provides reports on activity and findings, Schedule audits, prepare documents, oversee all logistics, Communicate any critical compliance risks noted from these activities to senior management.
May lead or participate in agency inspections (preparation, conduct, and responses).
May work with Director on global monitoring initiatives
May develop policies/work instructions related to quality management
Local travel required for monitoring of affiliate/satellite sites
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 laws.
Participates in required training and education programs.
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 research... 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.