Regulatory Affairs Associate - Medicine

at  Baylor College of Medicine

SUMMARY

Regular Affairs Associate under Medicine Clinical Trials Administration Unit will support investigators who are interested in starting a new clinical trial study. This person is responsible for reviewing and coordinating the regulatory and administrative requirements for conducting research; provides guidance in the accumulation of regulatory documentation, provide daily study support such as recruiting study subject, data entry to investigators when requested. This person will work alongside other members of the clinical trial administration unit and department research administration team to ensure a successful trial is established.
This position will initially be on-site, with the opportunity to transition to a hybrid work model after the initial training period.

MINIMUM QUALIFICATIONS

• Bachelor’s degree.
• Two years of relevant experience.

PREFERRED QUALIFICATIONS

• Master’s degree.
• Good communication/inter-person skills, accountable, organized, self-motivated, team player, works well under pressure, multitasking.
  Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

• Works with financial analyst, PI to assess budgetary needs on clinical trial studies (protocol reviews) - 15%
• Manages clinical study regulatory work for research studies or clinical trials. 20%
• Assists with regulatory affairs training. 10%
• Assist with IND/IDE submission and reporting to the FDA and other government agencies. 10%
• Submits study protocols in institutional online portal (BRAIN and CTA system) 15%
• Communicates with IRBs and PIs related to submissions, renewals, and adverse events. 10%
• Serves as main contact for investigators, sponsors, government agencies, and the IRB. 10%
• Supports daily operations for a research study or clinical trial. 5%
• Recruits, screens, and enrolls study participants; ensures participant adherence to study protocol. 5%