1+ months

Clinical Research Specialist

Cedars-Sinai Medical Center
Los Angeles, CA 90006
**Join Cedars-Sinai!** Align yourself with an organization that has a reputation for excellence! Cedars Sinai was awarded the National Research Corporations 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 Companys 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 Americas 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 Clinical Research Specialist provides clinical research expertise by participating in the design and implementation of research projects and care of research patients as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). **Duties and Responsibilities:** + Provides clinical research expertise by participating in the design and implementation of research projects and care of research patients as needed by the department or institution. + Responsible for specific and assigned aspects of research infrastructure development and/or maintenance. + Coordinates research projects at an institutional or departmental level. Serves as an internal consultant for specific departmental activities. + Communicates project status and improvement areas with leadership in a timely manner. Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees. + Implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. + Provides guidance regarding project planning, project logistics, and project implementation + Participates in required training and education programs. Participates in weekly research staff meetings. + Provides clinical expertise and support with quality assurance, performance improvement, and health plan compliance for clinical trial compliance. + Ensures the completion and maintenance of consent forms, case report forms, SAEs and source documents to ensure that research is being conducted according FDA, HSPC, HIPAA an d other agency guidelines. + Completes appropriate IRB paperwork and submission/filing of internal and external SAEs to IRB. Responsible for insuring timely submission of complete, accurate and neat documents to research sponsors, IRB, and contract research organizations, where applicable. + Acts as a liaison with Principal Investigators, pharmaceutical company representatives and other project funding organizations to monitor and update project progress. + Prepares for institutional, pharmaceutical and internal audits, including facilitating third party study monitoring. + Attends site feasibility visits and site initiation visits for potential studies, and assures that new studies are implemented according to protocol. + Review pertinent medical records to determine opportunities for quality improvement. Analyze quality metric data in support of the Principal Investigator and Director of Clinical Services. Recommend and implement process improvement efforts. + Assists with procedures, and supports related patient care when required during data collection process. Serves as a resource and mentor to other research staff by providing training, work review and leading staff. + Provides guidance, instruction and expertise to team members on study requirements and clinical coordination of the studies. + May assist with grant proposals, publication preparation, and/or presentations. + May process, ship, track or otherwise handle research specimens. **Work Experience:** + 5+ years in area of clinical research + 5+ years in IRB clinical research application procedures. Related experience in Pharmaceutical/Biotechnology, or Contract Research Organization (CRO) preferred + 5+ years in Phase I, II, III, IV clinical trials and investigator initiated trials preferred **Licenses and Certifications:** + BLS + Certification in Clinical Research (SOCRA or ACPR) + Phlebotomy certification CA preferred + Certified registered Medical Assistant preferred **Working Title:** Clinical Research Specialist **Department:** Angeles Research **Business Entity:** Medical Network Foundation **Job Category:** ,Academic/Research,Academic/Research **Job Specialty:** Research Studies/Clinical Trials **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.

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Posted: 2021-12-13 Expires: 2022-10-27

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Clinical Research Specialist

Cedars-Sinai Medical Center
Los Angeles, CA 90006

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