Research Associate II

Requisition # HRC0749546

Join Cedars-Sinai!

Align yourself with an organization that has a reputation for excellence! Cedars Sinai was awarded the National Research Corporation’s Consumer Choice Award 19 years in a row for providing the highest-quality medical care in Los Angeles. We also were awarded the Advisory Board Company’s Workplace of the Year. This annual award recognizes hospitals and health systems nationwide that have outstanding levels of employee engagement. We provide an outstanding benefits package, along with competitive compensation. Join us! Discover why U.S. News & World Report has named us one of America’s Best Hospitals.

The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. We are committed to bringing innovative therapeutic options to all our patients with cancer. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care!

What will you be doing in this role?

The Research Associate for Regulatory Affairs performs a wide variety of start-up activities integral to the successful application and acceptance of essential regulatory documents. The Research Associate is responsible for insuring timely submission of complete, accurate and neat documents to research sponsors, IRB, and contract research organizations, where applicable.

Duties and Responsibilities:

• Submits research projects (protocols, consent forms, recruitment materials, IRB application, etc.) for human subjects’ approval.
• Submits appropriate internal documentation for contract execution. Maintain communication with contracting officers and sponsors of research during the budgeting and negotiating process.
• 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.
• Monitors study payments and generates invoices as necessary to ensure adequate funding throughout the course of the trial.
• Ensures timely annual renewal of IRB approvals and consent forms for studies.
• 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, HSPC, HIPAA and other agency guidelines.
• Maintains regulatory files (financial disclosures, FDA forms, CVs, medical licenses, etc.) for clinical trials.
• Completes appropriate IRB paperwork and submission/filing of internal and external Serious Adverse Events (SAEs) to IRB.
• Maintains accurate records of honoraria and consulting fees for principal investigators for financial disclosures.
• Ensures that research is being conducted according to FDA, HSPC, HIPAA and other agency guidelines.
• Coordinates and prepares for institutional, pharmaceutical and internal audits.
• Coordinates site feasibility visits and site initiation visits for potential studies.
• Coordinates and collaborates with in-house and outside 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. Obtain necessary consent forms, or HIPAA information forms as needed, in research process.

Education:

• Master’s Degree (MS/MA/MPH Degree, preferably in a scientific/health care field required

Work Experience:

• Related experience in Pharmaceutical/Biotechnology required
• Experienced in federal grant proposal development and grant submissions and knowledge of IRB clinical research application procedures preferred

• Working Title: Research Associate II
• Department: Angeles Research
• Business Entity: Medical Network Foundation
• City: Los Angeles
• Job Category: Family & Function, Medical Network Foundation
• Job Specialty: UNASSIGNED
• 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 [email protected] 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) and COVID-19. 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 April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines such as COVID-19 as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.

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