The California Precision Medicine Consortium (CaPMC) is part of the national All of Us Precision Medicine Research Program which seeks to enroll 1 million participants living in the United States to contribute their health data for research. This national study will provide researchers and scientists access to bio specimens, genetic data, medical records, and person-generated health data to advance precision medicine in the U.S. CaPMC includes UC Davis, UC San Diego, UC Irvine, UC San Francisco, USC, and Cedars Sinai. Clinical Research Associates for this research program will work with the research team to review communication materials and implement social media strategies to advance public understanding of precision medicine and the All of Us research program!
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The Clinical Research Associate I works directly with the research team to coordinate and/or implement the study. They will analyze research data and ensure compliance with protocol and research objectives. The CRA I will assist with entering data and help with regulatory submissions to the Institutional Review Board (IRB).
Essential Job Duties
Collaborates with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
Evaluates and abstracts data from source documents.
Confirms protocol compliance and clinical research objectives.
Completes Case Report Forms (CRFs).
Enters data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with submissions to the IRB and works closely with managing 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.
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 IRB.
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
Works primarily with the engagement lead, project lead, and study coordinators to assist the engagement team.
May work remotely, on campus, and occasionally be asked to work off-site at events (under the supervision of study lead and/or study coordinators).
Participates weekly check-ins and team meetings.
Assist team with planning and implementation of social media strategies.
Interact with participants by answering and returning telephone calls.
Answer participant questions and provide information regarding the study, explaining procedures, and consent process.
Interact with online users and triage online comments to appropriate personnel.
Report issues or concerns to engagement/study leads as they arise and maintain good communication with team.
Assist with other engagement and recruitment activities, as appropriate, to improve visibility and awareness for the program.
May lead all aspects of the pick-up and delivery of clinical research-related items such as bio specimens.
Associate Degree or College Diploma, required.
BA/BS degree, preferred.
Practical understanding of social media platforms.
Understanding of general research objectives.
Working Title: Clinical Research Associate I Per Diem - All of Us Research Program
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.