Clinical Research Compliance Architect

Houston Methodist; Houston (TX); On-site; USD 60,000 - 90,000; Full time

Job summary

Houston Methodist is looking for a Regulatory Compliance Specialist to coordinate regulatory processes and maintain documentation for clinical research studies. The role requires a Bachelor’s degree and two years of relevant experience, preferably in medical devices or pharmaceuticals.

The specialist will address regulatory compliance, assist in training personnel, and ensure protocols meet FDA standards. Strong English skills and proficiency in Excel, Word, and PowerPoint are required.

Qualifications

• Two years of clinical research, regulatory compliance, or equivalent applicable work experience.
• Experience in medical devices, diagnostics, or pharmaceuticals highly preferred.

Responsibilities

• Coordinate and perform regulatory processes like IRB submissions.
• Maintain documentation for clinical research studies.
• Assist in training study personnel on regulatory and safety reporting.

Skills

Proficient speaking, reading, and writing English

Knowledge and application of process improvement tools

Interpersonal skills

Computer skills in Excel, Word, and PowerPoint

Education

Bachelor’s degree or higher

Tools

Excel

Word

PowerPoint

Job description

Houston Methodist is looking for a Regulatory Compliance Specialist to coordinate regulatory processes and maintain documentation for clinical research studies. The role requires a Bachelor’s degree and two years of relevant experience, preferably in medical devices or pharmaceuticals.

The specialist will address regulatory compliance, assist in training personnel, and ensure protocols meet FDA standards. Strong English skills and proficiency in Excel, Word, and PowerPoint are required.