Clinical Research Associate Ii/Certified Phlebotomy Technician (Cpt) - Cancer Biobank

The Clinical Research Associate II/CPT 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.
• 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.
• Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Schedules research participants for research visits and research procedures.
• Serves as the point of contact for external sponsors for select trials.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• 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
• Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
• Completes Case Report Forms (CRFs).
• May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications
• Coordinates activities of other associates to ensure compliance with protocol and overall clinical research objectives.
• Assists with clinical trial budgets.
• Evaluates and abstracts clinical research data from source documents.
• Participates in required training and education programs. May be involved in training and education of other Clinical Research Associates.
• Provides supervised contact with research participants or contact for long term follow-up research participants only.

Department Specific Duties:

• Cancer Institute: Performs Phlebotomy duties
• Performs biospecimen documentation and processing.
• Conducts patient chart reviews.
• Consents patients for research.

Requirements:

• 1 year-Clinical Research Related Experience
• High School Diploma/GED required

Preferred:

• SOCRA or ACRP certification, preferred
• Bachelor's Degree-Degree in Science, Sociology or related degree, preferred

Physical Demands:

Standing, Walking, Sitting, Lifting - 50 lbs., Carrying - 50 lbs., Pushing - 50 lbs., Pulling - 50 lbs., Climbing, Balancing, Stooping, Eye/Hand/Foot Coordination, Crouching, Crawling, Reaching, Handling, Grasping, Feeling, Talking, Hearing, Repetitive Motions, Kneeling

Working Title: Clinical Research Associate II/Certified Phlebotomy Technician (CPT) - Cancer Biobank
Department: Cancer Institute
Business Entity: Cedars-Sinai Medical Center
Job Category: Family & Function,Cedars-Sinai Medical Center,Family & Function,Cedars-Sinai Medical Center
Job Specialty: UNASSIGNED
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$21.26 - $36.14