Senior Clinical Trials Associate — Regulatory & Site Support

Bausch + Lomb; Austin (TX); On-site; USD 85,000 - 115,000; Full time

Job summary

Bausch + Lomb, a global eye health leader, seeks a Clinical Operations professional to support the execution, conduct, and closeout of clinical studies under the Director, Clinical Operations. You will coordinate protocol development, regulatory submissions, TMF management, and site communications, ensuring adherence to GCP and FDA requirements.

The role emphasizes collaboration with CTM/Sr. CTM and cross-functional teams, with opportunities to contribute to compliant, efficient trial operations

Qualifications

• Bachelor's degree in a health profession or science; advanced degree a plus.
• At least 3 years of ongoing clinical trials experience.
• Demonstrated proficiency in knowledge of GCPs and FDA regulatory requirements.
• Knowledge of medical terminology.
• Ability to work independently.
• Excellent verbal and written communication skills; computer proficiency (Word, Excel, Outlook).
• Travel may be required (minimal).

Responsibilities

• Collaborates with CTM/Sr. CTM on tasks before and during clinical trials, including protocol development, CRF development, IRB submissions, site selection, and TMF preparation.
• Ensure compliance with FDA and international regulatory requirements and SOPs during all clinical investigations and post-market studies.
• Communicate with clinical trial sites regarding conduct, monitoring, logistics, and study visits to ensure protocol and GCP compliance.
• Assist in tracking payments and invoices for studies.
• Provide operational support to ensure efficient cross-functional processes and systems.
• Collaborate with Research and Development, Regulatory, Safety, and Quality/Compliance teams.
• Support administrative documents related to study programs, TMFs, and startup activities.
• Assist and support presentations of clinical information for specific projects.
• Handle projects with moderate-to-high difficulty requiring analysis and sound judgment.

Skills

GCP knowledge

FDA regulations

Medical terminology

Independent working

Communication

Computer skills

Travel

Education

Bachelor's degree

Tools

Word

Excel

Outlook

Job description

Bausch + Lomb, a global eye health leader, seeks a Clinical Operations professional to support the execution, conduct, and closeout of clinical studies under the Director, Clinical Operations. You will coordinate protocol development, regulatory submissions, TMF management, and site communications, ensuring adherence to GCP and FDA requirements.

The role emphasizes collaboration with CTM/Sr. CTM and cross-functional teams, with opportunities to contribute to compliant, efficient trial operations