"Clinical Research Associate I - Dept of Orthopaedics/Orthopedic Foot & Ankle research program"

Job Description

Join our team and use your skill with an organization known nationally for excellence in research!

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.

Principal Responsibilities:

• Works under the direction of a Clinical Research Coordinator, Research Program Administrator 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.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits
• 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

Education:

High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or a related field preferred

Experience and Skills:

No experience required. One (1) year of clinical research related experience is preferred.

Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations.

Ability to convey and/or receive written/verbal information to/from various audiences in different formats.