Clinical Research Associate , Per Diem - Dept of Orthopaedics

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 and implementation of non‑complex research studies. The role supports study objectives through data collection, prescreening, and scheduling of research participants, assistance with IRB submission activities, budgeting and billing, and ensuring overall compliance with federal and local guidelines.

• Assist in tasks supporting the coordination and implementation of non‑complex research studies under the direction of supervising staff.
• Collect, evaluate, and abstract clinical research data, and assist in designing data collection forms.
• Enter and process study data into Electronic Data Capture (EDC) systems provided by sponsors.
• Complete Case Report Forms (CRFs).
• Prescreen potential research participants, schedule research visits and procedures, and provide patient contact for long‑term follow‑up patients.
• Assist supervising staff with regulatory submissions to the Institutional Review Board (IRB), including adverse event reporting and safety letters.
• Prepare and ship study samples, and maintain study supplies and kits.
• Serve as point‑of‑contact for external sponsors for select trials, respond to sponsor inquiries, and attend study activity meetings under the direction of supervising staff.
• Ensure compliance with HIPAA regulations and applicable law.

Education: High School Diploma or GED required. Bachelor’s degree in Science, Sociology, or a related field preferred.

Experience and Skills: No experience required; one year of clinical research related experience preferred. Ability to interpret and apply State, Federal, and Agency standards to align with regulations. Ability to convey and receive written and verbal information to/from a variety of audiences in different formats.