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Sr Research Compliance AnalystRequisition # 18000771 Apply Now
Summary of Essential Job Duties:
The Senior Clinical Research Compliance Analyst is a professional position working under the general supervision of Manager, Research Compliance and Quality Improvement. The incumbent will provide high-level professional support to assist the Manager in the continuous development, support and expansion of the Research Compliance and IRB Post-Approval Monitoring Program.
1.Develop educational materials and tools to support compliance with FDA regulations for sponsor-investigators and proper research files and research documentation.
2.Provide consultation and support to investigators in the development of investigator-initiated FDA regulated clinical trials to ensure consistency throughout protocol documents and that the protocol contains adequate detail to ensure compliance.
3.Conduct site initiation visits to ensure that sponsor-investigators and their research teams are prepared to conduct their studies in compliance with the IRB-approved protocols and all applicable regulatory requirements before enrollment begins.
4.Serve as an independent quality assurance monitor for investigator-sponsored studies, developing monitoring plans and SOPs, conducting monitoring visits, writing reports, and following-up on deficiencies and items for follow-up.
5.Provide guidance and support to investigators related to registration and results reporting on ClinicalTrials.gov.
6.Provide additional support to sponsor-investigators on a case by case basis, after agreement for such services is reached between the investigator and ORCQI Director, in areas of protocol development, database consultation, development of protocol training materials, creation of data and safety monitoring plan, and case report form creation.
7.Serve as team lead to audit ongoing human research protocols on a regular basis to ensure that the investigators’ practice conforms to applicable regulations, policies, ethical principles, and IRB approved protocols. Drafts detailed reports outlining audit findings, recommendations, and corrective actions.
8.AuditIRB records maintained by the ORCQI to assist in quality assurance and continuous performance improvement efforts.
9.Assistthe Manager in the resolution of subject inquiries and complaints and allegations of non-compliance, as needed.
10.Trackfindings from both internal and external audits, monitoring activities, and compliance issues in an effective manner for presentation in the Quality Improvement Program Annual Report, to identify topics for educational efforts, and to provide general guidance and education to IRB staff, IRB members, investigators and research staff on compliance-related matters.
11.Together with the Manager, provide support to investigators undergoing external audit by sponsors or regulatory agencies and assist with coordination and support of any external audit of the IRB.
12.Conduct special projects as assigned by the Manager, Research Compliance and Quality Improvement or the Director of Research Compliance and Quality Improvement.
Bachelor's degree required
Master's or doctoral degree preferred
A certification of "Certified IRB Professional" or "Certified Clinical Research Personnel" or equivalent is required
Minimum of 5 years experience in IRB (or IACUC) administration, research compliance, biomedical research, or the equivalent. Direct experience in IRB or IACUC administration is preferred
Physical ability and perceptive acuity to perform functions
- Working Title: Sr Research Compliance Analyst
- Business Entity: Academic / Research
- City: Los Angeles
- Job Category: Compliance/Quality
- Job Specialty: Research Compliance
- 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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