Clinical Trials Specialist — Operations & Compliance

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

401(k) with company match

Tuition reimbursement

Company holidays

Well-being benefits

Sick leave

Floating holidays

Paid vacation

Job summary

Bausch + Lomb is seeking a detail-oriented clinical operations professional to support the planning, conduct and closeout of clinical studies, ensuring adherence to GCPs and FDA requirements.

Under the Director, Clinical Operations, you will collaborate with CTM teams and sites, assist TMF documentation, monitor study activities and manage payments, while contributing to multiple projects across R&D, Regulatory, Safety and Quality/Compliance.

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 effectively work independently.
• Excellent verbal and written communication skills plus computer proficiency (Word, Excel, Outlook).
• Travel may be required (minimal).

Responsibilities

• Collaborates with CTM/Sr. CTM on protocol development, CRF, IRB submissions, site selection, TMF prep and training.
• Supports regulatory compliance with FDA and SOPs during investigations.
• Coordinates with sites on study conduct, monitoring, logistics and closeout visits.
• Assists in tracking study payments and invoices.
• Provides operational support to ensure workflows and systems run efficiently.
• Collaborates with R&D, Regulatory, Safety and Quality/Compliance teams.
• Supports TMFs and start-up activities across study programs.
• Assists with presentations of clinical information for projects.
• Handles tasks of moderate-to-high difficulty requiring judgment.

Job description

Bausch + Lomb is seeking a detail-oriented clinical operations professional to support the planning, conduct and closeout of clinical studies, ensuring adherence to GCPs and FDA requirements.

Under the Director, Clinical Operations, you will collaborate with CTM teams and sites, assist TMF documentation, monitor study activities and manage payments, while contributing to multiple projects across R&D, Regulatory, Safety and Quality/Compliance.