Senior Clinical Trials Operations Specialist

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

Benefits offered by this job

Health insurance

401(k) plan with company match

Tuition reimbursement

Paid vacation

Job summary

Bausch + Lomb is seeking a Clinical Operations professional to support the implementation, conduct, and closeout of clinical studies, ensuring compliance with regulatory standards and SOPs. The role involves collaboration with CTM and cross-functional teams to manage trial documentation, sites, and workflow.

Responsibilities include protocol development, monitoring, and TMF management, with travel requirements being minimal.

Qualifications

• Bachelor’s degree in health profession or science; advanced degree a plus.
• At least 3 years of ongoing clinical trials experience.
• Proficiency in GCPs and FDA regulatory requirements.
• Knowledge of medical terminology.
• Ability to work independently.
• Excellent verbal and written communication; computer proficiency.

Responsibilities

• Collaborates with CTM on tasks before clinical trials: protocol development, CRF, IRB submissions, ICF development, site selection, TMF structure, training.
• Ensures compliance with FDA and international regulatory requirements; adheres to SOPs during investigations and post-market studies.
• Communicates with clinical trial sites regarding study conduct, monitoring, logistics, follow-up, and close-out visits for protocol adherence.
• Assists in tracking study payments and invoices.
• Provides workflow support to ensure cross-functional processes are completed efficiently.
• Collaborates with R&D, Regulatory, Safety, and Quality/Compliance teams.
• Supports study startup activities with administrative documents and TMFs.
• Assists in presenting clinical information for specific projects.
• Tackles moderate-to-high difficulty projects requiring judgment and flexibility.

Skills

GCP knowledge

FDA regulations

Medical terminology

Communication skills

Education

Bachelor's degree in health/science

Advanced degree a plus

Tools

Word

Excel

Outlook

Job description

Bausch + Lomb is seeking a Clinical Operations professional to support the implementation, conduct, and closeout of clinical studies, ensuring compliance with regulatory standards and SOPs. The role involves collaboration with CTM and cross-functional teams to manage trial documentation, sites, and workflow.

Responsibilities include protocol development, monitoring, and TMF management, with travel requirements being minimal.