When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.
The Chen Laboratory is unraveling basic mechanisms of lung injury and repair. Our focus is on how lung epithelial cells interact with other cellular compartments and with the extracellular matrix to regulate inflammatory cell recruitment and lung fibrosis in various cell-based and animal models. To learn more, please visit: Chen Research Lab | Cedars-Sinai (cedars-sinai.org)
The Clinical Research Associate I (CRA I) will work 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 (CRFs), entering clinical research data, and assist with regulatory submissions to the Institutional Review Board (IRB). The CRA I may have limited contact with research participants as needed for study and assists with study budget and research participant billing. This role complies with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Job Duties and Responsibilities:
Enter clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Provide supervised contact with research participants or contact for long term follow-up research participants only.
Works closely with supervising research staff or directly with the IRB to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets, patient research billing and schedules patients for research visits and research procedures
Responsible for sample preparation and shipping and maintenance of study supplies and kits
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
Department Specific Job Responsibilities:
Assists with regulatory sponsor paperwork for clinical trials and prescreens potential subjects for various clinical trials
Chart abstraction for chart review studies
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, and phone numbers
Performs literature reviews and searches for manuscripts and research proposals, and 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 t...eaching 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.