Research Compliance Specialist – Audit, Training & COI

1004 Lehigh Valley Hospital; Allentown (Lehigh County); On-site; USD 70,000 - 95,000; Full time

Job summary

Lehigh Valley Health Network is seeking a Research Compliance Auditor to conduct routine and for-cause audits, prepare detailed reports, and ensure adherence to FDA, OHRP, DHHS, GCP, ORI, AAHRPP guidelines. The role supports investigators, manages COI disclosures, and trains staff on compliance processes.

The position requires a Bachelor’s Degree and at least 2 years in a clinical research setting, with strong attention to detail and communications skills.

Qualifications

• Bachelor’s Degree required.
• 2 years of experience in a clinical research environment.
• Ability to work with personnel at all levels to gather information, communicate compliance requirements, and handle complex issues.
• Knowledge of regulations regarding the use of human subjects in clinical trials, outcomes research, nursing research, and other research areas.
• Strong attention to detail and ability to adhere to policies and procedures.

Responsibilities

• Conducts routine and for-cause compliance audits to ensure accuracy, privacy, and security of participant information.
• Prepares audit reports to present to research investigators; reviews/assists in the development of corrective and preventative action plans (CAPA).
• Reviews and manages research-related compliance matters, allegations of research noncompliance, and related topics; maintains all case records.
• Assembles case documents to present to committees; writes and processes letters of determination and management plans.
• Manages a tracking system for COI disclosures and serves as a resource to Investigators.

Education

Bachelor’s Degree

Bachelor’s Degree in nursing or health-related field

Job description

Lehigh Valley Health Network is seeking a Research Compliance Auditor to conduct routine and for-cause audits, prepare detailed reports, and ensure adherence to FDA, OHRP, DHHS, GCP, ORI, AAHRPP guidelines. The role supports investigators, manages COI disclosures, and trains staff on compliance processes.

The position requires a Bachelor’s Degree and at least 2 years in a clinical research setting, with strong attention to detail and communications skills.