Job Description
Grow your career at Cedars-Sinai! Join our team and use your skills with an organization known nationally for excellence in research! The Research Associate II works at a high level of excellence and commitment to perform a wide variety of activities integral to the successful management and administration of essential regulatory documents. The Research Associate II is responsible for ensuring timely submission of complete, accurate and current documents to research sponsors, IRBs, and contract research organizations, where applicable.
Duties include;
- Submits research projects (protocols, consent forms, recruitment materials, IRB application, etc.) for human subjects' approval.
- Submits appropriate internal documentation for contract execution. Maintains communication with contracting officers and sponsors of research during the budgeting and negotiating process.
- Monitors study payments and generates invoices as necessary to ensure adequate funding throughout the course of the trial
- Ensures timely filing of annual renewals and amendment submissions to IRB
- Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according to IRB, FDA, OHRP, HIPAA and other agency guidelines
- Maintains high quality, up-to-date regulatory files (CITI and other training documents, financial disclosures, FDA forms, CVs, medical licenses, etc.) for research studies
- Completes appropriate IRB paperwork and submits internal and external Serious Adverse Events (SAEs) and INDSRs to IRB
- May help coordinate and prepare for institutional, pharmaceutical and internal audits
- Coordinates site feasibility visits and site initiation visits for potential studies. Completes feasibility questionnaires
- Provides facility tours to visiting research sponsors, CROs, and other personnel for research-related activities
- Coordinates and collaborates with internal and external investigators and participating centers in multi-center studies to achieve research goals
- Participates in weekly research staff meetings
- Protects rights and research data of research volunteers, including medical records, data, etc. Obtains necessary consent forms, or HIPAA information forms as needed, in research process
- Performs administrative duties in a timely manner as assigned
- Develops research project budgets based on protocol requirements and Cedars-Sinai published research costs, ensuring that all anticipated costs are appropriately accommodated and that research protocol, research budget and research subject informed consent documents are consistent.
Qualifications- High School Diploma/GED required
- BS/BA degree, preferably in a scientific/health care field preferred
- 1 year clinical research or relevant experience
About Us Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the Team With a growing number of primary urgent and specialty care locations across Southern California, Cedars-Sinai's medical network serves people near where they live. Delivering coordinated, compassionate healthcare you can join our network of clinicians and physicians to improve the healthcare people throughout Los Angeles and beyond.
Req ID : 3353
Working Title : Research Associate II - The Angeles Clinic & Research Institute (TACRI)
Department : Angeles Research Inst
Business Entity : Cedars-Sinai Medical Care Foundation
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $21.70 - $32.55
