Senior Regulatory Affairs Associate

4 weeks ago

Houston, Texas, United States Baylor College of Medicine Full time


Summary

This role will primarily be responsible for the overall implementation and management of clinical studies that are regulated under the European Union General Data Protection Regulation or GDPR, and specifically, how GDPR information must be provided to research subjects, including privacy notices and consent forms, as well as managing studies under the Clinical Trials Support Office. This role provides support to address questions of the EU GDPR (European Union General Data Protection Regulation) regarding human subjects' research in clinical studies and how the enrollment of certain individuals/research subjects is documented, in addition to the US Common Rule CFR 46 Subpart A, and Informed Consent documentation.

This role is eligible for a hybrid work schedule.

Job Duties

  • Manages all components of the BCM GDPR program.
  • Develops and reports on performance metrics for the program.
  • Develops, reviews, and maintains the program's policies and procedures.
  • Develops, reviews, and maintains templates, tools, and guidance documents needed for the program's function.
  • Creates and delivers relevant workshops, presentations, and other educational materials and opportunities; leverages external training to benefit the program and research activities; effectively communicates the program's objectives to appropriate stakeholders.
  • Maintains the program's website.
  • Participates in long-range planning of the program's activities.
  • Maintains current knowledge of the regulatory environment, especially regulations changes and guidance documents applicable to European Union research.
  • Assists monitoring team and provides a review of ongoing monitoring reports as needed.
  • Assists with internal and external audits; prepares corrective actions, if necessary.
  • Provides regulatory administrative and clerical support.

Minimum Qualifications

  • Bachelor's degree.
  • Four years of relevant experience.

Preferred Qualifications

  • Certification as a Certified Clinical Research Professional (CCRP), or Clinical Research Associate (CRA)
  • Experience in regulatory writing and regulatory submission work
  • Knowledge of clinical research practices and principles
  • Well-versed in human subjects' research requirements and guidance according to the applicable Code of Federal Regulations (21 CFR parts 50, 54, 312, and 812), the provisions of the HHS Common Rule (46 CFR 45), and ICH GCP (E6) guidelines
  • Ability to work independently and drive processes
  • Ability to manage projects
  • Ability to work in a team and demonstrated interpersonal skills
  • Must have and exhibit computer skills and possess exemplary writing and verbal skills
  • Must have and exhibit attention to detail and excellent organizational skills
  • Must have excellent time management skills, including the ability to manage multiple and competing priorities
  • Excellent customer service skills, including the ability to interact effectively with diverse stakeholders, including faculty and research staff

Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

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