Clinical Research Compliance Specialist

2 weeks ago


Towson, Maryland, United States United Urology Group Full time
Job Title: Clinical Research Compliance Specialist

United Urology Group is seeking a highly skilled Clinical Research Compliance Specialist to join our team. As a key member of our research compliance team, you will be responsible for ensuring that all study personnel within UUG are compliant with ICH guidelines, federal regulations, and internal standard operation procedures.

Key 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.
Requirements:
  • 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).
What We Offer:
  • Competitive salary and benefits package.
  • Opportunity to work with a leading urology network in the country.
  • Chance to make a difference in patient care.
  • Collaborative and dynamic work environment.

United Urology Group is an equal opportunity employer and welcomes applications from diverse candidates. The successful candidate will be subject to a pre-employment background check.



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