Research Regulatory Specialist and Educator - ClinicalTrials.gov (PartialRemote)

Research Regulatory Specialist and Educator - ClinicalTrials.gov (PartialRemote)

The University of Texas Medical Branch | Galveston, TX, 77554, US
Salary Range:$54,000 – $76,000 Salary range estimated by Zippia

Posted 16 days ago

Apply Now

Description



Minimum Qualifications:
Bachelor’s Degree or equivalent and 5 years of related experience

Job Summary:
Maintains ClinicalTrials.gov database, ensuring that PRS records comply with applicable regulations and are proactively maintained. Assists faculty with the completion and submission of PRS records, IND/IDE applications/amendments, FDA reporting. Maintains Responsible Conduct of Research Database and tracks completion of required trainings. Leads workshops that provide education and training in these areas. Assists in the development, implementation, and maintenance of regulatory policies and the delivery of timely service to customers. Assists with the creation of standard operating procedures. Maintains other databases that connect research projects. Under the direction of the Director of Research Integrity and Regulatory Affairs, Research Regulatory Specialist completes tasks towards the management of their portfolio. 
Scope:  This position interacts with organizational units spanning Research Regulations and Compliance (RRC), Research Administration (RA), school and departments, central UTMB administration, University of Texas System, State and Federal agencies, and accrediting organizations.

Job Duties:
The ideal candidate will be knowledgeable of research rules and regulations beyond the fundamentals in ClinicalTrials.gov and IND/IDE applications and reporting, a confident public speaker, and a devoted educator who is current on the latest tools and resources needed to improve faculty and staff experiences related to research compliance and administration as they conduct research. The specialist will also be responsible for researching and selecting the best platform to deliver and utilize training materials. In addition, they will provide regulatory expertise to the research active community ensuring that research processes and policies are adhered to. UTMB as a medical institution is heavily active in clinical and biomedical research but is open to other forms of research as well. The specialist should be knowledgeable of policies that are applied by governing bodies such as the federal government, state government, sponsors such as the National Institutes of Health (NIH), Department of Defense and the National Science Foundation, international regulatory bodies such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and UTMB policy and guidelines. The specialist:

  • Develops and coordinates procedures and programs to enhance investigator understanding and compliance with ClinicalTrials.gov, the Responsible Conduct of Research and items related to research integrity
  • Provides regulatory expertise to the research community to ensure that IRB approved research is entered into external systems as needed for additional compliance (ClinicalTrials.gov, CDER NextGen, etc)
  • Assist researchers with outcomes reporting to various stakeholders including but not limited to ClinicalTrials.gov, FDA
  • Serves as a primary resource to the research community as a regulatory expert and trainer regarding all aspects of research compliance related to clinical trials
  • Provides analysis of study processes to identify opportunities to enhance compliance, efficiency, and effectiveness.
  • Creates and delivers training, workshops, and education programs in support of the objectives of RIRA including but not limited to the responsible conduct of research and undue foreign influence in research, ClinicalTrials.gov use, IND/IDE applications
  • Communicates concerns about research compliance with the Director to ensure timely addressing of said concerns
  • Prepares and assists in preparing annual reports and quality trending reports.
  • Identifies and escalates IRB protocol deviations, noncompliance with reporting, data discrepancies, etc. in research projects to the Director after documented efforts with the project PI fails
  • Collaborates with adjacent research administration offices as needed such as the Office for Clinical Research, Office of Sponsored Programs, Institutional Review Board, Office of Institutional Compliance
  • Keeps abreast of federal regulations ergo current with research compliance
  • Manages and maintains databases related to research compliance activities
  • May serve as subject matter expertise to Information Technology in support of business objectives and initiatives, especially as it relates to interfacing and supporting the regulatory data.
  • Reports the status of the quality levels of staff, systems, and production activities
  • Evaluates research-related events, incidents, queries, and complaints
  • Assists with the monitoring of research projects that are approved by the IRB to ensure compliance and alignment with the approved IRB protocol and GCP guidelines
  • Develops and implements of standard operating procedures and institutional policies and procedures
  • Audits records in accordance with UTMB IHOPs and RIRA’s SOPs to ensure that research projects are conducted in accordance with relevant rules and regulations
  • Disseminates information to the research community
  • Adheres to internal controls and reporting structure
  • Performs related duties as required
  • Assist with institutional policy creation as needed
  • Supports all aspects of regulatory compliance
  • General ad hoc reports as requested


 

Knowledge/Skills/Abilities

  • Hands-on, solutions-oriented professional with a can-do attitude guided by regulatory boundaries but with the willingness to reach out to regulating bodies for additional guidance when necessary.
  • Demonstrated knowledge of research regulatory requirements
  • Respond to customer questions in a timely manner
  • Submit deadline-driven documents on time
  • Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands
  • High attention to detail and accuracy
  • Ability to engage with internal and external stakeholders effectively to establish productive working relationships across a diverse campus and external stakeholders
  • Fosters collaborative relationships with colleagues, faculty, and management of the university
  • Proactive management of compliance-related items on research projects
  • Understands that the Office of Research Integrity and Regulatory Affairs is a support office and as such so is each member of the RIRA team
  • Skilled and organized individual with demonstrated ability to follow up on tasks independently.
  • A team player who works effectively in a complex, matrix organization
  • Exceptional organizational skills and a focus on results that ensure timely progress on execution priorities


 

Preferred Qualifications:

  • Two (2) years in any one of the following fields – Export Controls Coordinator, Responsible Conduct of Research Coordinator, Compliance Specialist, ClinicalTrials.gov Coordinator, Department Research Administrator, or Three (3) years of experience in developing training programs
  • Understands and can successfully apply knowledge of research regulations and concepts of research administration
  • Willing to cross-train in the office


 

Preferred Certification:

Certified Research Administrator (CRA), Clinical Research Associate (CRA) Certification, 

 

Salary Range:

Actual salary commensurate with experience.

 

Work Schedule:

Monday through Friday, 8am to 5pm and as needed on occasion.

 

EQUAL EMPLOYMENT OPPORTUNITY:
UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a VEVRAA Federal Contractor, UTMB Health takes affirmative action to hire and advance women, minorities, protected veterans and individuals with disabilities. 



Compensation