Regulatory Compliance Specialist

Summary

This position will guide investigators through the IRB review process and assist with the preparation and submission of protocol documents to the IRB and other regulatory committees, ensuring regulatory compliance. Responsible for supporting the implementation and maintenance of the compliance program, including conducting audits, providing training, monitoring compliance activities, and assisting with investigations to promote a culture of ethical conduct and mitigate compliance risks within the organization.

• Advising researchers and research teams on the requirements and standards for conducting approved research studies. Develop tools and resources to promote compliance and participate in education activities to support and guide researchers.
• Investigate, review, and report compliance concerns and reported events.
• Participate in compliance‑related committees and subcommittees, providing updates on compliance activities and contributing to discussions on compliance, policy, and similar matters.
• Administer the semiannual program review and facility inspection process, ensuring all deficiencies are identified and corrected, and prepare the report to the Institutional Official.
• Point of contact for all Federal, State, and local inspections, and accreditation site visits, as applicable.
• Conduct regular audits and risk assessments to identify potential compliance issues.
• Provide ongoing education on coding updates and changes in regulatory requirements.

Bachelor's Degree Related Field of Study required

Previous Compliance experience 2-3 years required

• Ability to work independently and with a team.
• Proficient written and verbal communication skills.
• Proficient organizational and attention to detail skills.
• Proficient understanding of federal regulations, such as the Common Rule, HIPAA, and other relevant research compliance standards.
• Proficiency in using Microsoft Office and other relevant software applications.
• Knowledge of current and developing clinical research trends.

The General Hospital Corporation is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.