Clinical Trial Associate – COE & Inspection Readiness

PTC Therapeutics, Inc; Baltimore (MD); On-site; USD 48,000 - 80,000; Full time

Job summary

PTC Therapeutics, Inc. in Baltimore is seeking a Contractor, Clinical Trial Associate (CTA) to support the COE function within Clinical Operations.

The role provides day-to-day operational and administrative support across standards, readiness, systems, and vendor alliances to ensure inspection-ready documentation and compliant processes. The CTA will assist with regulatory adherence, SOPs, and maintenance of COE documents, training materials, and quality checks, while working in a fast-paced,

Qualifications

• Bachelor's degree in a relevant discipline; 5+ years of clinical operations experience.
• Working knowledge of ICH-GCP and clinical documentation practices.
• Ability to manage multiple projects with strong organizational skills.

Responsibilities

• Coordinate COE initiatives, deliverables, and timelines.
• Coordinate COE meeting logistics & action-item tracking.
• Maintain COE repositories (SharePoint/Teams) and ensure content is searchable.
• Develop and maintain best practices, job aids, and onboarding materials for Clinical Operations.
• Support SOPs, templates, tools, and guidance documentation and perform document control activities.

Skills

ICH-GCP knowledge

Planning & time management

Attention to detail

Microsoft Office proficiency

Effective communication

Independent & collaborative work

Analytical thinking

Education

Bachelor's degree in relevant discipline

Tools

CTMS

eTMF

LMS/eLearning

Job description

PTC Therapeutics, Inc. in Baltimore is seeking a Contractor, Clinical Trial Associate (CTA) to support the COE function within Clinical Operations.

The role provides day-to-day operational and administrative support across standards, readiness, systems, and vendor alliances to ensure inspection-ready documentation and compliant processes. The CTA will assist with regulatory adherence, SOPs, and maintenance of COE documents, training materials, and quality checks, while working in a fast-paced,