Clinical Trials Operations Associate — GCP & Regulatory

Bausch + Lomb; Augusta (ME); 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) plan with company match

Tuition reimbursement

Paid holidays

Well-being benefits

Sick time

Paid vacation

Job summary

Bausch + Lomb is seeking a Clinical Operations professional to support the implementation, conduct and closeout of clinical studies in accordance with the Investigational Plan and all applicable regulations. Under the supervision of the Director, Clinical Operations, you will help plan protocols, develop CRFs, submit IRB materials and coordinate site activities.

This role requires a Bachelor’s degree in a health discipline, at least 3 years of trials experience, knowledge of GCP and FDA

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 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 tasks prior to commencement of clinical trials (planning, protocol development, CRF development, IRB submissions, ICF development, site selection, TMF structure, documentation, training).
• Supports regulatory compliance with FDA and international regulations and SOPs during investigations.
• Communicates with clinical trial sites regarding study conduct, follow-up, and close-out visits per protocols and GCP.
• Assists in tracking study payments and invoices.
• Provides workflow support to ensure efficient cross-functional processes.
• Collaborates with R&D, Regulatory, Safety, and Quality/Compliance teams.
• Supports TMFs and startup activities with administrative documents.
• Assists in presenting clinical information for projects.

Skills

GCP knowledge

FDA regulatory knowledge

Medical terminology

Independent work

Verbal communication

Written communication

Travel willingness

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 in accordance with the Investigational Plan and all applicable regulations. Under the supervision of the Director, Clinical Operations, you will help plan protocols, develop CRFs, submit IRB materials and coordinate site activities.

This role requires a Bachelor’s degree in a health discipline, at least 3 years of trials experience, knowledge of GCP and FDA