Senior Clinical Trial Associate

Role Summary

Senior Clinical Trial Associate responsible for supporting the planning, execution, and management of clinical trials, including trial documentation, coordinating with internal and external stakeholders, and ensuring regulatory compliance.

Responsibilities

• Administrative and project support for Clinical Operations
• Assist in the planning, initiation, and execution of clinical trials in compliance with regulatory requirements (FDA, ICH-GCP, etc.).
• Support the maintenance and organization of trial master files (TMF) and essential documents.
• Support study start-up activities, including site selection, ethics committee submissions, and contract execution.
• Coordinate communication between study sites, sponsors, CROs, and other vendors.
• Track and manage study documents such as informed consent forms, protocols, case report forms (CRFs), and investigator brochures.
• Assist in preparing study materials, site training documents, and monitoring visit reports.
• Monitor trial progress and ensure timely data collection and entry.
• Assist in budgeting, invoicing, and financial tracking for clinical trials.
• Ensure compliance with company SOPs, Good Clinical Practice (GCP), and other applicable guidelines.

Qualifications

• Bachelor’s or Master’s degree in life sciences, healthcare, or a related field.
• 4+ years of related experience. Prior experience at a CRO or investigative site preferred. Entry level candidates will be considered if education and project management skills are demonstrated.
• Current knowledge of FDA and ICH Guidelines, including Good Clinical Practices (GCP) requirements
• Excellent communication and collaboration skills to work with cross-functional teams.
• Strong attention to detail and organizational and time management skills
• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus
• Travel may be required (5%)
• Must be able to write clearly and summarize information effectively.

Skills

• Clinical trial coordination
• Regulatory compliance (FDA, ICH-GCP, GCP)
• TMF management
• Documentation and communication
• Budgeting and financial tracking
• Cross-functional collaboration
• Microsoft Office; proficiency with project tools a plus

Education

• Bachelor’s or Master’s degree in life sciences, healthcare, or related field

Additional Requirements

• Travel may be required (5%)