Heart Institute - Clinical Research Assoc I/CPT, Susan Cheng Team

Primary Duties And Responsibilities

• Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies.
• Collections, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction.
• Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Completes Case Report Forms (CRFs).
• Affords assistance in prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only.
• Affords assistance to supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
• Affords assistance with clinical trial budgets and patient research billing.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Ensures compliance with protocol and overall clinical research objectives. 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.
• Serves as one point of contact for external sponsors for select trials. Responds to sponsor inquiries and attends meetings regarding study activity under the direction of supervising staff.

Qualifications

• Educational Requirements: High school diploma/GED required Bachelor's degree in Science, Sociology or related degree preferred
• Licenses: CPT- Phlebotomy Certification license required
• Experience: 1 Year Clinical Research Experience Preferred

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.