Summary

Baylor College of Medicine Department of Otolaryngology's Research Division is looking for a Regulatory Affairs Associate who will be responsible for coordinating the regulatory and administrative requirements for conducting research. The ideal candidate will also provide guidance in the accumulation of regulatory documentation.

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC)are eligible for certification pay.

Job Duties

• Manages clinical study regulatory work for a research study or clinical trial.
• May assist with regulatory affairs training.
• May assist with IND/IDE submission and reporting to the FDA and other government agencies.
• Communicates with IRBs and PIs related to submissions, renewals, and adverse events.
• Creates regulatory reports as needed/requested.
• Serves as main contact for investigators, sponsors, government agencies, and the IRB.
• Explains facts, policies and practices related to job area to internal stakeholders and counterparts.
• Communicates with contacts both within and outside of job area on matters that require some explanation or interpretation.
• Influences parties within job area regarding concepts, practices and approaches.
• May provide guidance, help with training and review work of entry level employees.
• May lead parts of less complex projects or processes.
• Performs other job-related duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with limited experience.