The Dan L. Duncan Comprehensive Cancer Center (DLDCCC) has an immediate opening for a Senior Regulatory Affairs Associate. This position will provide regulatory support for clinical trials coordinated through the DLDCCC Clinical Trials Support Unit (CTSU). Applicants must possess strong working knowledge of human research regulations (ICH GCP, FDA, OHRP) as well as have familiarity with the logistics of conducting clinical trials in an academic research environment. The ideal candidate is detail-oriented, able to successfully manage competing priorities/projects and able to quickly adapt to a variety of situations.
Senior Regulatory Affairs Associate is responsible for coordinating the regulatory and administrative requirements for conducting research; provides guidance in the accumulation of regulatory documentation.
Prepare clinical trial submissions for review (initial and continuing reviews, and protocol amendments) by appropriate internal and external regulatory agencies and oversight bodies, including the IRB, FDA, RAC, and IBC.
Assist investigators and senior CTSU staff with the development and writing of clinical trial protocols and informed consent documents.
Develop and maintain positive relationships with regulatory agencies and other oversight bodies to serve as a liaison between the various stakeholders (investigators, sponsors, CROs and oversight bodies).
Assist CTSU Management with training and mentoring of junior regulatory staff as well as the development and updating of guidance documents and best practices.
Maintain protocol regulatory files to ensure all records are up-to-date, accurate, and compliant with federal and institutional regulations, and CTSU SOPs.
Notify investigators and study staff of protocol updates, and distribute current protocols and consent forms.
Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors. Assist Investigators with responses to regulatory agencies or sponsors.
Prepare regulatory reports and coordinate data collection and reporting with other departments.
Provide regulatory guidance to investigators and study staff regarding protocol requirements, federal and institutional regulations, and internal SOPs.
Maintain working knowledge of current regulations through guidelines, articles, writings and courses.
Assist with data collection and reporting of Serious Adverse Events and/or Unanticipated Problems to appropriate regulatory agencies and sponsors.
Attend continuing education and training opportunities relevant to job duties.
Four years of relevant experience.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care.
- Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective.
- Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve.
- Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.