Cedars-Sinai Clinical Reseach Associate I - Per Diem - All of Us in Beverly Hills, California
The California Precision Medicine Consortium (CaPMC) is part of the national All of Us Precision Medicine Research Program which aims to enroll 1 million participants living in the U.S. to contribute their health data for research. This national study will provide researchers and scientists access to biospecimens, 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.
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse 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 patient contact as needed for study and assist with study budget and patient research billing. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse 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 patient contact or patient contact for long term follow-up patients 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.
DEPARTMENT AND/OR UNIT SPECIFIC – ESSENTIAL JOB RESPONSIBILITIES:
Works primarily with the engagement lead, project lead, and study coordinators to assist the engagement team for the program.
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).
Attends 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 promote visibility and awareness for the program.
May be responsible for the pick-up and delivery of clinical research-related items such as biospecimens.
BA/BS degree, or equivalent combination of education & experience
Understanding of general research objectives
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.