Clinical Research Specialist I - Quality Management CoreRequisition # 20002414 Apply Now
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.
BA/BS degree required
ACRP/SoCRA (or equivalent) certification preferred.
Three (3) years minimum experience in area of research specialty.
- Working Title: Clinical Research Specialist I - Quality Management Core
- 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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