Job Description

The Clinical Research Associate I 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. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.

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.
• Collects, 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). Assists with 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.
• Assists 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.
• Assists 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.
• May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.

Qualifications

This is a per diem position, offering flexibility to work anywhere from 0 to 40 hours per week, depending on the needs of the department. Scheduling will be determined by the hiring manager based on operational priorities.

Please note that per diem team members are not eligible for health benefits, but this role provides an excellent opportunity to gain valuable experience, contribute to meaningful work, and enjoy a flexible schedule.

Requirements:

• High School Diploma/GED required.

Preferred:

• Bachelor's Degree preferred.
• 1 year Clinical research related experience preferred.