Senior Clinical Trials Associate - Regulatory & Ops

Bausch + Lomb

Boise (ID)

On-site

USD 85,000 - 115,000

Full time

8 days ago
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Benefits offered by this job

Medical, dental, vision insurance
401(k) with company match
Tuition reimbursement
Paid time off
Life insurance

Job summary

Bausch + Lomb in Boise, Idaho seeks a clinical operations professional to support the planning, conduct and closeout of clinical studies, ensuring adherence to the Investigational Plan and regulatory requirements.

The role collaborates with CTMs, regulatory, quality, and safety teams, handling study documentation, TMFs, site communications, and study start-up activities, with opportunities for career growth in a global eye-health leader.

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 work independently.
  • Excellent verbal and written communication skills, plus computer proficiency.

Responsibilities

  • Collaborates with CTM/Sr. CTM on clinical planning, protocol development, CRF development, IRB submissions, and site communications.
  • Supports regulatory and SOP compliance during investigations and post-market studies.
  • Coordinates study conduct, monitoring, and closeout visits ensuring protocol and GCP adherence.
  • Assists in tracking payments and invoices for studies.
  • Provides workflow support for TMFs and cross-functional systems.

Skills

GCP knowledge
FDA compliance
Communication

Education

Bachelor's degree in health/science

Tools

Word
Excel
Outlook

Job description

Bausch + Lomb in Boise, Idaho seeks a clinical operations professional to support the planning, conduct and closeout of clinical studies, ensuring adherence to the Investigational Plan and regulatory requirements.

The role collaborates with CTMs, regulatory, quality, and safety teams, handling study documentation, TMFs, site communications, and study start-up activities, with opportunities for career growth in a global eye-health leader.

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