Clinical Trial Associate I

Role Summary

The Clinical Trial Associate I (CTA) is a key support role within Clinical Operations, contributing to the execution of clinical trials for patients with rare and serious diseases. The CTA provides essential administrative, documentation, and coordination support across all phases of clinical trial management. Working under Clinical Trial Managers (Lead CTMs and/or CTMs), the CTA ensures trial documentation is accurate, complete, and compliant, and that study activities are well-organized and efficiently executed in alignment with regulatory guidelines and PTC quality standards. Activities include study start-up, investigator site feasibility and selection, and essential document review related to site initiation, investigational product release, and patient enrollment. This role may also support project team meetings by capturing minutes and following up on action items to ensure tasks are completed.

Responsibilities

• Assist in the collection, review, and tracking of essential regulatory and clinical trial documents throughout the study lifecycle.
• Support the setup, organization, and maintenance of the Trial Master File (TMF), ensuring ongoing inspection readiness and compliance with ICH-GCP and internal SOPs.
• Coordinate clinical trial start-up, maintenance, and close-out activities, including preparation of study materials, meeting logistics, and distribution of study communications.
• Assist in the development and management of study trackers, tools, and logs (e.g., site contact lists, enrollment logs, action-item trackers).
• Schedule and support internal and external study meetings (investigator meetings, vendor calls, and cross-functional discussions); prepare agendas and meeting minutes as needed.
• Interface with Clinical Research Organizations, vendors, and clinical sites to support study-related tasks and documentation collection.
• Participate in review of monitoring reports and site-level documents such as informed consent forms and training logs.
• Support TMF quality control and audit preparation activities.
• Assist in maintaining clinical trial management systems (e.g., CTMS), ensuring timely updates and accuracy of study status and documentation.
• Facilitate and support study-level contracting and procurement workflows in partnership with Legal and Finance, leveraging enterprise systems.
• Collaborate with cross-functional teams (e.g., Regulatory, Data Management, Clinical Supplies) to support ongoing study operations.
• Participate in onsite co-monitoring and monitoring oversight visits with CTM.
• Perform other tasks and assignments as needed and specified by management.

Qualifications

• Bachelor’s degree in a relevant life science or healthcare-related discipline and minimum 2 years of clinical research support experience in a pharmaceutical, biotechnology, or related environment or a recognized equivalent of education and experience.
• Familiarity with clinical trial study documents.
• Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint).
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Experience with TMFs, including performing periodic ad hoc, interim and end-of-study reviews/audits on paper and electronic TMFs to ensure TMF meets sponsor’s expectations (includes TMF reconciliation at study close-out).

Additional Requirements

• Travel: 10-15%