Research Associate II - The Angeles Clinic & Research Institute

Overview The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and 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 hire 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. 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 budgeting and negotiating processes. Develops research project budgets based on protocol requirements and Cedars-Sinai published research costs, ensuring that all anticipated costs are accommodated and that research protocol, research budget and 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 the IRB. Ensures the completion and maintenance of consent forms, case report forms, SAEs and source documents to ensure that research is conducted in accordance with 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 INDs/IRs to the IRB as required. 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 as needed. 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 and data; obtains necessary consent forms or HIPAA information forms as needed in research processes. Performs administrative duties in a timely manner as assigned. Qualifications High School Diploma/GED required. Bachelor's degree preferred. 1 year Clinical research related experience required. #J-18808-Ljbffr Cedars-Sinai