Cedars-Sinai Clinical Research Coordinator II - Neurology - Night in Los Angeles, California
Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements. Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our researchers develop some of the most advanced clinical trials in the world. Here, you will be a part of leading-edge cancer research history that improves our cancer patients' treatment options, one trial at a time.
Do you have a passion for helping human kind?
As a member of our team, you will bring your dedication and expertise to collaborate on clinical trials and assist on research studies. You will provide support and service to faculty and staff conducting research. This includes coordination of staff support, provision of centralized systems, regulatory expertise, and quality assurance. Your work will support our mission of rapidly translating research discoveries into safe, effective treatments.
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.
Four (4) years minimum of directly related experience in the field of clinical trial coordination. Must have strong MS Office computer skills, conduct Internet searches, and ability to become proficient using related organizational and sponsor software programs.
ACRP / SoCRA (or equivalent) preferred
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.