The department of neurology provides patients with access to clinical trials and research aimed at improving testing methods, treatments, quality of life and recovery. As a member of the team, the Clinical Research Coordinator II works independently and in collaboration with national and internationally known clinical investigators providing study coordination for studies affecting the central nervous system, such as Multiple Sclerosis, Parkinson's disease, Alzheimer's disease, neurovascular/stroke, epilepsy and others with the goal and passion for understanding neurological conditions and advancing treatments options for our community. For more information on clinical trials within neurology, please visit https://www.cedars-sinai.org/programs/neurology-neurosurgery/clinical-trials.html.
Specific duties include but are not limited to:
Independent study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details to the research participants, and participating in the informed consent process.
Scheduling of research participants for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Works closely with directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and central and local Institutional Review Boards of record.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc. Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency.
Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
May identify new research opportunities and present to investigators. Participates in required training and education programs.
May conduct bio-specimen processing and shipment according to IATA standards and regulations.
Works with department research administrator on budget development as it relates to study specific procedures and responsible for patient research billing reconciliation.
Cedars-Sinai Medical Center is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) for all research involving the protection of patients. AAHRPP is a Washington, DC, based non-profit organization that uses voluntary, peer-driven, educational model to accredit institutions engaged in research involving human subjects.
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research... and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.