Remote Clinical Trials Associate, GCP & Study Ops

Bausch & Lomb GmbH; United States; Remote; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) match

Tuition reimbursement

Paid time off

Remote work option

Job summary

Bausch + Lomb is seeking a Clinical Operations professional to support the implementation, conduct, and closeout of clinical studies in compliance with ICH-GCP and FDA regulations. The role involves protocol development, documentation, site coordination, and TMF management from remote locations in the US.

The candidate should have a minimum of 3 years in clinical trials, strong communication, and the ability to work independently.

Qualifications

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

Responsibilities

• Collaborates with CTM/Sr. CTM on protocol development, CRF creation, IRB submissions, ICF development, site selection, and TMF prep.
• Supports regulatory compliance with FDA and international requirements and SOPs.
• Assists in site communications regarding study conduct, monitoring, and visit closeouts to ensure GCP adherence.
• Tracks study-specific payments and invoices.
• Provides operational support to ensure cross-functional processes run smoothly.
• Collaborates with R&D, Regulatory, Safety, and Quality/Compliance teams.
• Prepares and maintains administrative documents related to TMFs and start-up activities.
• Assists in presenting clinical information for specific projects.
• Handles moderate-to-high complexity tasks requiring judgment and flexibility.

Skills

GCP knowledge

FDA regulatory requirements

Medical terminology

Independent work

Verbal and written communication

Computer proficiency

Education

Bachelor’s degree in health profession/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 in compliance with ICH-GCP and FDA regulations. The role involves protocol development, documentation, site coordination, and TMF management from remote locations in the US.

The candidate should have a minimum of 3 years in clinical trials, strong communication, and the ability to work independently.