Regulatory Affairs Associate — Clinical Trials (Hybrid)

Baylor College of Medicine; Houston (TX); Hybrid; USD 71,000 - 83,000; Full time

Job summary

Baylor College of Medicine in Houston is seeking a Regulatory Affairs Associate for the Clinical Research Division to guide investigators through regulatory and administrative requirements for new and ongoing clinical studies.

The role collaborates with investigators, sponsors, and IRB offices; responsibilities include preparing regulatory documentation, coordinating submissions (IND/IDE), and supporting trial operations in a hybrid work setting.

Qualifications

• Bachelor's degree required.
• Two years of relevant experience.
• Excellent written and oral communication skills.
• Knowledge of medical/scientific terminology.

Responsibilities

• Reviews and coordinates regulatory requirements for proposed clinical research studies.
• Supports IND/IDE submissions and reporting to FDA and other agencies.
• Assists with regulatory documentation and compliance for trials.
• Serves as main contact for investigators, sponsors, IRB, and regulatory authorities.

Education

Bachelor's degree

Tools

Microsoft Office Suite

Job description

Baylor College of Medicine in Houston is seeking a Regulatory Affairs Associate for the Clinical Research Division to guide investigators through regulatory and administrative requirements for new and ongoing clinical studies.

The role collaborates with investigators, sponsors, and IRB offices; responsibilities include preparing regulatory documentation, coordinating submissions (IND/IDE), and supporting trial operations in a hybrid work setting.