Clinical Trials Operations Specialist

Parexel International; Northern (KY); Hybrid; USD 52,000 - 85,000; Full time

Job summary

Parexel International is seeking a Clinical Trial Associate to provide operational and administrative support across trial lifecycles, ensuring adherence to ICH-GCP and client SOPs, and helping deliver study deliverables on time.

You will maintain study tracking, coordinate documentation, support TMF archiving, and collaborate with study teams to address issues while keeping regulators and vendors informed.

Qualifications

• BS/BA degree or degree in healthcare field required.
• 1+ years in pharma/biotech OR 2 years in a CRO environment.
• Foundational knowledge of clinical trial processes and ICH-GCP/CFR.
• Effective written and verbal communication; teamwork.
• Proficient with MS Office Suite and study tracking tools.
• Familiarity with eTMF systems (VeevaVault preferred) and TMF archiving.

Responsibilities

• Assist with organizing, updating and maintaining tracking systems for studies from start-up to closeout.
• Coordinate development of study management tools, monitoring tools, manuals and training materials.
• Schedule meetings, prepare agendas, minutes, and action items.
• Maintain study files and shared spaces in compliance with requirements.
• Coordinate and track study training and vendor interactions.
• Support project-specific activities for Study Management.

Skills

Experience in clinical operations

Strong communication skills

Organizational skills

MS Office proficiency

Team collaboration

Attention to detail

Education

BS/BA degree in healthcare field

Tools

Veeva Vault

Job description

Parexel International is seeking a Clinical Trial Associate to provide operational and administrative support across trial lifecycles, ensuring adherence to ICH-GCP and client SOPs, and helping deliver study deliverables on time.

You will maintain study tracking, coordinate documentation, support TMF archiving, and collaborate with study teams to address issues while keeping regulators and vendors informed.