Clinical Trials Operations Specialist (GCP/Regulatory)

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

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Tuition reimbursement program

Paid holidays and well-being benefits

Job summary

Bausch + Lomb in the United States seeks a Clinical Trials Support professional to assist the Director, Clinical Operations, with study planning, site coordination and regulatory compliance across trials.

The role emphasizes collaboration with R&D, Regulatory, Safety, and Quality teams, ensuring TMFs are prepared and study materials are accurate, while maintaining strong communication with trial sites and internal stakeholders.

Qualifications

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

Responsibilities

• Collaborates and supports CTM/Sr. CTM on required tasks prior to commencement of clinical trials (planning, protocol development, CRF development, IRB submissions, site selection, TMF structure, training).
• Supports regulatory compliance with FDA and international requirements during investigations and post-market studies.
• Communicates with clinical trial sites regarding conduct, monitoring, logistics, follow-up and close-out visits to ensure protocol and GCP compliance.
• Assists in tracking study payments and invoices.
• Provides operational support to ensure departmental systems are completed efficiently.

Skills

GCP knowledge

FDA regulatory knowledge

Medical terminology

Independent work

Verbal & written communication

Education

Bachelor’s degree in health profession or science

Advanced degree a plus

Tools

Word

Excel

Outlook

Job description

Bausch + Lomb in the United States seeks a Clinical Trials Support professional to assist the Director, Clinical Operations, with study planning, site coordination and regulatory compliance across trials.

The role emphasizes collaboration with R&D, Regulatory, Safety, and Quality teams, ensuring TMFs are prepared and study materials are accurate, while maintaining strong communication with trial sites and internal stakeholders.