Job Description

Clinical Research Associate II - The Angeles Clinic & Research Institute at CEDARS-SINAI summary:

The Clinical Research Associate II at The Angeles Clinic & Research Institute manages and submits regulatory documents essential for clinical trials, ensuring compliance with IRB, FDA, and other agency guidelines. They coordinate study budgets, communications with sponsors, and enrollment documentation while facilitating audits and site visits. This role supports multi-center research studies to advance innovative cancer therapies and maintain high-quality research standards.

Job Description

Grow your career at Cedars-Sinai!

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. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all our patients with cancer.

Why work here?

Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for.

Join our team and contribute to groundbreaking 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.

Primary 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. Maintains 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 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.

Qualifications

Requirements:

• High School Diploma/GED required. Bachelor's degree preferred.
• 1 year Clinical research related experience required.

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Req ID : 12058
Working Title : Clinical Research Associate II - The Angeles Clinic & Research Institute
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 : $24.65 - $38.21

Keywords:

clinical research, regulatory compliance, clinical trials, IRB submissions, research budgeting, data management, cancer research, patient consent, multi-center studies, clinical trial coordination

Job Tags

Contract work, Shift work,

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