Cedars-Sinai Clinical Research Associate I - Pulmonary Research in Los Angeles, California
Are you ready to be a part of breakthrough research?
Cedars-Sinai is home to some of the most sophisticated biomedical research and training programs in the world, which attracts renowned physician-scientists seeking an unparalleled environment for encouraging invention and teamwork. Investigators from Pulmonary Research have active and productive interactions with local colleagues at the University of Southern California and UCLA, as well as with top programs throughout the world.
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. The incumbent will provide 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.
Primary Duties and Responsibilities:
Enters data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Provides supervised contact with study participants or contact for long term follow-up research participants only.
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 and patient research billing.
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 Duties and Responsibilities:
Assists with prescreening of potential participants for various clinical trials.
Assists with regulatory sponsor paperwork for clinical trials.
Assists with preparing for and submission of IRB documents.
Maintains organized paper and electronic research files.
Performs chart abstraction for chart review studies.
Attends monthly conference calls with sponsors.
Maintains organization of various research databases to include REDCap, Oncore, and Invio/SourceDrive.
Performs all data collection and data entry tasks for departmental clinical trials.
Tracks research participants for required follow-up visits and maintains accurate research documentation.
Acquires required signatures on various documents such as Adverse Event Forms, Severe Adverse Events Forms, etc.
Maintains frequent intra- and inter-institutional communication to gather and maintain data for researchers.
Performs literature reviews.
- High School Diploma/GED is required
Understanding of general clinical research objectives.
1-2 years of clinical research experience is highly preferred.
Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
Working Title: Clinical Research Associate I - Pulmonary Research
Department: Home Dept - Pulmonary
Business Entity: Academic / Research
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.