Clinical Trial Associate

Overview

• Provide clinical operational support to Clinical Trial Teams throughout the lifecycle of clinical trials in a remote setting.
• Assist with the start-up, execution, and close-out phases of clinical trials with meticulous attention to detail.
• Act as a central point of contact for project communications, correspondence, and documentation for clinical trial teams.
• Maintain and organize electronic Trial Master File (eTMF) and SharePoint sites for clinical study documentation.
• Coordinate internal and external meeting agendas, minutes, and distribution for Clinical Trial Teams.
• Support the preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
• Assist with trial-specific tracking reports, including patient enrollment and regulatory documents.
• Collaborate with Quality Assurance to ensure team members are trained on trial-specific plans and documents.

Key Responsibilities & Duties

• Maintain inspection readiness and support responses to regulatory authority inspection audits.
• Coordinate with trial vendors throughout the clinical trial lifecycle and maintain vendor lists.
• Assist in resolving issues, questions, and process requests for additional study supplies.
• Support preparation of Clinical Study Reports and appendices as needed.
• Act as a backup for other Clinical Trial Associates when required.
• Provide updates on clinical trial status on ClinicalTrials.gov.
• Collaborate across different organizations and work as part of a team to support departmental initiatives.
• Assist in coordinating Investigator and third-party payments.

Job Requirements

• Bachelor of Science (BS) in life sciences or equivalent experience required.
• Minimum 2 years of experience in a clinical research environment, preferably in oncology.
• Knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements.
• Proficient in Microsoft Suite/Office, Adobe Acrobat, and Smartsheet.
• Experience utilizing various eTMF platforms and managing clinical study documentation.
• Strong interpersonal, organizational, written, and oral communication skills.
• Ability to prioritize tasks and manage multiple projects under tight deadlines.
• Handle sensitive and confidential information with discretion.