This part-time (10 hrs/week) Senior Regulatory Affairs Associate will assist with the submission of protocols and IND submissions to the FDA and relevant institutional review boards. Will support the Pediatric Cell and Gene Therapy section in the submission of pediatric brain tumor research proposals. The Senior Regulatory Affairs Associate will be working with the regulatory team that supports and submits all protocols for approvals through the IRB and FDA. This is part of our Clinical Research Office.
Protocol and FDA Submissions
Preparation of the 1571
Preparation of the Table of Contents and related section cover pages
Preparation of the 3674 - this may also require entry into clinicaltrials.gov
Preparation of the Environmental Exclusion memo
Preparation of the 1572s and collation of the related CV/biosketches - collection of CV/biosketches
Create/Obtain all components of the 10 point IND as specified in 5.1 of the SOP. Of note the CGTMP will actually be a PBTC based monitoring plan
Review the protocol, draft consent form, P/T, CMC, and Introductory Statement/General Inv Plan for consistency
Work with the PIs to modify/obtain the correct documents for the submission
After finalizing the submission it must be combined into a single pdf which is then hyperlinked for submission to the FDA
Submission of protocol documents to IRB and communicating with IRB and PIs related to submissions and approvals
Four years of relevant experience.
Previous experience with cancer protocols and cell and gene therapy studies is preferred.
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.