Job DescriptionThe Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB.Provides limited patient contact with research participants as needed for study and assist with study budget and patient research participant research billing. In addition, the CRA II may coordinate activities, training, and education for other Clinical Research Associates. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.Primary Duties and Responsibilities
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.
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.
Schedules research participants 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. May be involved in training and education of other Clinical Research Associates.
Serves as the point of contact for external sponsors for select trials.
Coordinates activities of other associates to ensure compliance with protocol and overall clinical research objectives.
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications
QualificationsRequirements:
High School Diploma/GED required. Bachelor's Degree preferred.
1 year of Clinical Research Related Experience required.
#Jobs-IndeedReq ID : 2323Working Title : Clinical Research Associate II, Data Coordinator (Hybrid)Department : Cancer - SOCCI Clinical ResearchBusiness Entity : Cedars-Sinai Medical CenterJob Category : Academic / ResearchJob Specialty : Research Studies/ Clin TrialOvertime Status : NONEXEMPTPrimary Shift : DayShift Duration : 8 hourBase Pay : $23.00 - $36.14Cedars-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.