Clinical Research Compliance Specialist

The Clinical Research Compliance Specialist is responsible for ensuring that all study personnel within UUG are compliant with ICH guidelines, federal regulations, and internal standard operation procedures.

Primary Duties & Responsibilities:

• Assess research operations to evaluate and determine compliance risk.

• Continuation of training and preparations for FDA inspections.

• Conduct internal monitoring review of research staff at all UUG research site locations nationally.

• Conduct a regulatory review of all established studies at all UUG research site locations nationally.

• Perform billing compliance checks.

• Review and confirm Medicare Coverage Analysis for protocols.

• Prepare for Sponsor-initiated audits.

• Assist in FDA inspections.

• Create new protocol templates and all amendments to protocols in CTMS.

• Prepare reports detailing observations, risks, recommendations, and all other compliance actions required.

• Assist with Internal Audit and or monitoring as requested by Research Area Directors.

• Participate in onboarding of new hires, including SOP review.

• Conduct focus training with research staff.

• Present summaries and findings from internal audits to the Research Compliance Committee.

• Perform other office duties as assigned by the Regulatory Manager.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.

Qualifications:

• Bachelor’s degree required or equivalent combination of experience, education, and/or certifications

• Minimum of 3-5 years clinical research experience.

• Certification in Clinical Research (CCRP/CCRC/CCRA) and/or CHRC or obtained within one year of hire

• Maintained certification of accreditation (CCRC/IATA/CPR/HSP/CITI).

Key Competencies:

• Proficient knowledge of Medical Terminology.

• Strong understanding of FDA clinical trial phases I-IV.

• Strong understanding of GCP, ICH Guidelines, FDA regulations, and regulatory agencies.

• Ability to use a clinical trials management system (CTMS)

• Highly detailed oriented and strong organizational skills.

• Ability to work independently with little supervision.

• Flexible hours and ability to travel to sites nationally.

• Excellent customer service skills.

• Strong written and verbal communication skills.

• Proficient computer software and database skills.

• Strong attention to detail and ability to stay organized.

• Ability to multi-task and work in a fast-paced environment.

Travel:

• Travel out of state to all National UUG research locations quarterly

• Out of State travel days can, at times, occur on a weekend day, as needed.