Senior Clinical Regulatory Compliance Lead

Houstonmethodistcareers; Houston (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Professional attire

Job summary

Houston Methodist is seeking a Senior Regulatory Compliance Specialist to lead regulatory processes and local IRB submissions in line with GCP and applicable laws. The role includes maintaining study documentation and supporting FDA-related activities across multiple studies.

Qualified candidates typically hold a bachelor’s degree or higher with five years of experience in a research setting and RAC/CCRC/CCRP certification.

Qualifications

• Bachelor's degree or higher.
• Master's degree preferred.
• Five years of experience in relevant research program experience.
• Must have one of RAC/CCRC/CCRP certifications.
• Strong communication and data management skills.

Responsibilities

• Lead and coordinate study-specific regulatory processes and local IRB submissions.
• Maintain documentation for clinical studies and regulatory files.
• Communicate with regulatory affairs for FDA submissions across multiple studies.
• Support training of regulatory personnel and serve as a regulatory information resource.
• Identify improvement opportunities and support performance improvement initiatives.

Skills

Regulatory knowledge

Communication skills

Process improvement

Data entry and abstraction

Team collaboration

Independent work

Presentation skills

English proficiency

Education

Bachelor's degree

Master's degree preferred

Tools

Regulatory databases

Job description

Houston Methodist is seeking a Senior Regulatory Compliance Specialist to lead regulatory processes and local IRB submissions in line with GCP and applicable laws. The role includes maintaining study documentation and supporting FDA-related activities across multiple studies.

Qualified candidates typically hold a bachelor’s degree or higher with five years of experience in a research setting and RAC/CCRC/CCRP certification.