EXPERIENCE, EDUCATION AND SPECIALIZED KNOWLEDGE AND SKILLS:

• Bachelor’s degree in Life Sciences, Business Administration or related field required
• Understanding of clinical trial processes, GCP, and regulatory documentation is preferred.
• Strong organizational and time-management skills with high attention to detail.
• Effective written and verbal communication skills.
• Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint); familiarity with clinical trial management systems (CTMS) or document management platforms is a plus.
• Ability to work collaboratively in a cross-functional, fast-paced environment.
• Critical thinking, problem solving, ability to work independently
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
• Prioritize conflicting demands
• Work in a fast-paced, demanding and collaborative environment
• Knowledge of GCP guidelines and relevant regulatory requirements

OVERVIEW OF ROLE:

The Clinical Project Assistant (CPA) provides administrative and operational support to the Clinical Operations team, including site contracting and clinical site partnership functions. This role plays a key part in ensuring smooth coordination across study start-up, site engagement, and ongoing trial activities. The CPA works closely with Clinical Operations staff, contract management personnel, and site-facing teams to support the timely execution and maintenance of clinical trials.

ROLE AND RESPONSIBILITIES:

• Support Clinical Operations staff with administrative and operational tasks related to study planning, start-up, conduct, and close-out.
• Assist with the coordination and tracking of site contracting and budget negotiation activities, including the collection and organization of contract documents and approvals.
• Maintain tracking tools and databases for site activation status, contract progress, site performances, data and document submissions.
• Provide support to the Clinical Site Partner team by coordinating site communications, assisting with outreach logistics, and ensuring timely follow-up on site requests and issues.
• Provide support where needed with the Trial Master File (TMF), ensuring compliance with GCP, ICH guidelines, and internal SOPs.
• Support audit and inspection readiness efforts through document quality checks and TMF maintenance.
• Assist in the preparation and scheduling of internal and external meetings, including developing agendas, taking meeting minutes, and tracking action items.
• Support department training efforts
• Help develop and maintain study-specific tools such as trackers, logs, templates, and site contact lists.
• Contribute to process improvement initiatives across Clinical Operations and site management functions.
• All other duties as assigned