Clinical Trial Operations Associate I

PTC Therapeutics, Inc.; New Jersey; On-site; USD 82,000 - 103,000; Full time

Benefits offered by this job

Incentives (short- and long-term)

Medical/dental/vision benefits

Retirement savings plan

Job summary

PTC Therapeutics, Inc. is seeking a Clinical Trial Associate I to support the Clinical Operations team in executing trials for pediatric and rare diseases.

The CTA will manage essential documents, TMF maintenance, and study tracker updates, ensuring regulatory compliance and timely communication across vendors and sites. The role requires a Bachelor's degree in life sciences and at least 2 years of clinical research support experience, with strong organizational and GCP/ICH knowledge.

Qualifications

• Bachelor’s degree in a life science or healthcare discipline and 2+ years clinical research support experience.
• Familiarity with clinical trial study documents.
• Knowledge of GCP and ICH guidelines.
• Proficiency with MS Office Suite (Word, Excel, PowerPoint).
• Excellent written and verbal communication skills.
• Ability to work independently and in a matrixed team.
• Experience with TMFs in multiple trials is a plus.

Responsibilities

• Assists in collection, review, and tracking of regulatory and trial documents throughout the study lifecycle.
• Supports setup, organization, and maintenance of the TMF with inspection readiness.
• Helps coordinate start-up, maintenance, and close-out activities including meeting logistics.
• Maintains study trackers, logs, and site contact lists.
• Schedules and supports study meetings; prepares agendas and minutes.
• Interfaces with CROs, vendors, and clinical sites for task coordination.
• Reviews monitoring reports and site-level documents such as consent forms.
• Supports TMF quality control and audit prep activities.
• Maintains CTMS updates and study status documentation.
• Supports contracting and procurement workflows with Legal and Finance.
• Collaborates with Regulatory, Data Management, and Clinical Supplies teams.
• Participates in on-site co-monitoring and oversight visits.
• Performs other tasks as needed by management.

Skills

GCP knowledge

ICH guidelines

MS Office proficiency

Excellent communication

Independent work in fast-paced env

TMF familiarity

Education

Bachelor’s degree in life sciences or healthcare

Tools

CTMS

TMF management systems

Job description

PTC Therapeutics, Inc. is seeking a Clinical Trial Associate I to support the Clinical Operations team in executing trials for pediatric and rare diseases.

The CTA will manage essential documents, TMF maintenance, and study tracker updates, ensuring regulatory compliance and timely communication across vendors and sites. The role requires a Bachelor's degree in life sciences and at least 2 years of clinical research support experience, with strong organizational and GCP/ICH knowledge.