Clinical Research Compliance Auditor

Lehigh Valley Hospital, Inc.; Allentown (Lehigh County); On-site; USD 70,000 - 100,000; Full time

Job summary

Lehigh Valley Health Network is seeking a Research Compliance Specialist to conduct routine and for-cause audits, educate researchers on regulatory processes, and maintain comprehensive case records to ensure human subjects protections and protocol compliance.

The role requires a Bachelor’s degree and at least two years in a clinical research setting, with strong attention to detail and cross-functional collaboration across investigators and staff.

Qualifications

• Bachelor’s Degree required in a related field.
• 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 human subjects in clinical trials.
• Strong attention to detail and adherence to policies and procedures.

Responsibilities

• Conduct routine and for-cause compliance audits to ensure privacy, and security of participant information and compliance with all protocols and policies.
• Prepare audit reports and assist in development of CAPA plans.
• Manage research-related compliance matters, COI disclosures, and case records.
• Assemble case documents for RCC/COIC and process letters of determination and management plans.
• Conduct research training for investigators and staff on informed consent and regulatory processes.
• Stay current on FDA, OHRP, DHHS, GCP, ORI and other regulatory requirements.

Skills

Regulatory knowledge

Clinical research experience

Communication with stakeholders

Attention to detail

Education

Bachelor’s Degree

Job description

Lehigh Valley Health Network is seeking a Research Compliance Specialist to conduct routine and for-cause audits, educate researchers on regulatory processes, and maintain comprehensive case records to ensure human subjects protections and protocol compliance.

The role requires a Bachelor’s degree and at least two years in a clinical research setting, with strong attention to detail and cross-functional collaboration across investigators and staff.