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 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.
Summary of Essential Job Duties
With multiple research labs at Cedars-Sinai, our leading lung specialists and research scientists work together to pioneer new imaging technologies, therapies and minimally invasive surgical techniques. As a patient with us, you'll have the potential to participate in groundbreaking pulmonary clinical trials.
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited contact with research participants as needed for study and assists with study budget and research participant billing. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Works with a Clinical Research Coordinator, Research Program Administrator, Research Nurse or Principal Investigator to coordinate/implement study.
Evaluates and abstracts clinical research data from source documents.
Ensures compliance with protocol and overall clinical research objectives.
Completes Case Report Forms (CRFs).
Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Provides supervised contact with research participants or contact for long term follow-up research participants only.
Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets.
Assists with patient research billing.
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Assists with regulatory sponsor paperwork for clinical trial.
Chart abstraction for chart review studies.
Prescreens potential subjects for various clinical trails.
Attends monthly conference calls with sponsors.
Maintaining organization of various databases
Maintains awareness and follows-up with ancillary departments to ensure data are received timely.
Tracks research participants for periodic required follow-up
Maintains current addresses, contact info, phone numbers,
Performs literature reviews and searches for manuscripts and research proposals. Proofreads manuscripts, letters, and other documents.
Attends internal research meetings, takes meeting minutes, maintains and distributes accurate minutes.
Maintaining organized files, and e-files;
Relaying/running documents between various offices;
Obtaining needed signatures on various research documents; Organizing/scheduling/rescheduling research meetings; frequent communication with collaborating institutions; and other departments within institution; maintains current contact information for research collaborators.
Responds to sponsor emails regarding start-up activities and recruitment.
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.