Senior Regulatory Affairs Associate

30 Jul, 2020


Senior Regulatory Affairs Associate

Baylor College of Medicine
Houston, TX

The Senior Regulatory Affairs Associate works to support the Protocol Office and investigators associated with The Texas Children’s Cancer and Hematology Centers (TXCH). As a Senior Regulatory Affairs Associate in Regulatory Affairs, multi-faceted, complex pediatric oncology treatment protocols will be assigned. The role is expected to interface with other academic centers, NIH funded consortia, the National Cancer Institute, the Federal Drug Administration (FDA), and industry sponsors on highly sensitive and confidential projects. This position supports all aspects of regulatory compliance for a specified portfolio of clinical trials. This support includes, but is not limited to, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees and ensuring successful navigation of approval processes for clinical research. This position requires expertise and understanding of clinical research and applicable regulations.

Job Duties
  • Oversees regulatory process for pediatric oncology and hematology human subjects research.
  • Handles more complex regulatory assignments including multi-site studies and Investigator held INDs.
  • Coordinates regulatory correspondence across internal stakeholders and external institutions. Prepares protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of clinical research projects at the TXCH.
  • Prepares for FDA/sponsor meetings, inspections, and audits from regulatory authorities.
  • Is available on site during audit visit to reply to auditor inquiries.
  • Maintain and expands understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs.
  • Develops and maintains positive relationships with institutional review committees and sponsor through oral and written communications.
  • Acts as a liaison between institutional review committees, regulatory agencies and the investigators to ensure that protocols obtain applicable approvals, that protocol amendments are submitted appropriately and that annual renewals are obtained.
  • Facilitates investigators in reporting and responding to institutional review committees’ and other regulatory agencies’ inquiries or comments.
  • Provides input to the investigators in consent form creation and protocol editing.
  • Works closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
  • Assists with training of entry level employees as assigned.
  • Practices a high level of integrity and honesty in maintaining confidentiality.
Minimum Qualifications
  • Education Required: Bachelor’s degree.
  • Experience Required: Four years of relevant experience.
Preferred Qualifications
  • Experience in regulatory affairs for clinical research at academic medical center or hospital with knowledge of clinical research practices and regulations.
  • Demonstrated knowledge of regulatory processes and applicable regulations.
  • Ability to manage regulatory aspects of multiple research projects.
  • Certification in Clinical Research, SOCRA or other.
  • Knowledge and understanding of clinical research compliance, including OHRP, FDA and other federal regulations and requirements regarding human subjects research, including but not limited to GCPs and related ICH guidelines, informed consent, adverse event reporting and monitoring, and other human subjects research protection requirements.
  • Ability to serve as a resource to clinical investigators and staff.
  • Ability to manage shifting priorities in short time frames.
  • Knowledge of medical/scientific terminology.
  • Strong computer skills including Microsoft Office Suite.
  • Knowledge of the federal regulations and ICH GCP guidelines required.

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

Learn more here

Job posted: 2020-07-30