The Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. 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. In addition, the CRA II may coordinate activities, training, and education for other Clinical Research Associates. This role will comply with all federal, local, FDA, IRS, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Duties Include:
Enters clinical research data into Electronic Data Systems (EDCs) 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 accurate source documents related to all research procedures 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 serve as the point of contact for external sponsors for select trial.
May be involved in training and education of other Clinical Research Associates.
May coordinate activities of other associates to ensure compliance with protocol and overall clinical research objectives.
May have percent of effort in centralized activities such as Auditing, Standard Operating Procedure development, etc.
This staff member will be part of the Endometriosis Research Center at Cedars-Sinai Medical Center. They will assist with the collection of specimens and data for research, specimen management and preparation of specimens and data for use in an ongoing research studies.
Educational Requirements:
BA/BS degree
Licenses:
ACRP/SoCRA (or equivalent) certification preferred
Experience:
Two (2) years of related experience or equivalent combination of education and experience.
Physical Demands:
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 II Spine
Department: Dept of Orthopaedics
Business Entity: Cedars-Sinai Medical Center
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$21.26 – $36.14