Sr Regulatory Compliance Specialist

At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH).

This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes. The Sr Regulatory Compliance Specialist position maintains documentation for clinical research studies, case report forms and study and regulatory files. Under minimal supervision from the Manager or Director, this position identifies problem-solving issues of moderate to complex scope.

The Sr Regulatory Compliance Specialist position contributes directly to internal departmental monitoring and research education as identified by the Manager or Director.

• Exempt

• Bachelor’s degree or higher
• Master’s degree preferred

• Five years of experience in relevant research program experience

• Must have one of the following certifications:
  
  RAC
  - Regulatory Affairs Certifications (RAPS) orCCRC
  - Certified Clinical Research Coordinator (ACRP) or CCRP
  - Certified Clinical Research Professional (SOCRA)

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
• Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
• Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
• Demonstrates expert knowledge and application of process improvement tools and techniques (statistical process control tools and team tools)
• Demonstrates knowledge of regulatory and accrediting standards as they apply to performance improvement
• Ability to enter and abstract data using personal computer, as well as the ability to utilize data to facilitate the improvement and change in processes
• Ability to facilitate performance improvement teams, present data and promote a collaborative approach toward goal achievement
• Ability to work independently and interdependently
• Strong presentation skills and expertise in designing and implementing teams/educational offerings related to clinical quality

• Collaborates with cross-functional teams including key study personnel. Role models strong, positive communication skills to ensure cohesive, smooth operation of the department
• Assists in training regulatory personnel and others on regulatory and safety reporting regulations, processes, and procedures under the direct supervision of the Regulatory Compliance Manager (serves as a resource for regulatory information and guidance)
• Develops and maintains interpersonal relationships with a wide variety of healthcare professionals and hospital leadership. Maintains credibility with IRB and other regulatory agencies, Sponsors, vendors, patients, and co-workers
• Initiate’s improvement recommendations for department scores for employee engagement, i.e., peer-to-peer accountability

• Serves as subject matter expert in support of department functions. Defines problems, collects data, establishes facts, and draws valid conclusions and evidence-based performance improvement via measurable results
• Prepare and manage documents required to initiate investigational drugs trials. Prepares research protocols for IRB…