Clinical Trial Associate

Overview

• Support clinical trial operations remotely, ensuring seamless execution across all trial phases with a focus on quality and compliance.
• Coordinate and manage trial documentation, including electronic Trial Master File (eTMF) and regulatory submissions.
• Facilitate communication and collaboration among clinical trial teams, vendors, and stakeholders.
• Assist in trial-specific tracking, including patient enrollment and regulatory documentation updates.
• Prepare and distribute meeting agendas, minutes, and documentation for internal and external stakeholders.
• Collaborate with Quality Assurance to ensure team training and adherence to trial-specific protocols.
• Contribute to the preparation and archiving of clinical trial reports and documentation.
• Provide operational support throughout trial start-up, execution, and close-out phases.

Key Responsibilities & Duties

• Ensure inspection readiness and assist in responding to regulatory audits and inspections.
• Coordinate vendor relationships and maintain comprehensive vendor documentation.
• Resolve trial-related issues, including supply requests and process inquiries.
• Support the development of Clinical Study Reports and associated appendices.
• Provide updates and maintain trial information on ClinicalTrials.gov.
• Collaborate across departments to support organizational initiatives and trial success.
• Assist with investigator and third-party payment coordination and tracking.
• Act as a backup for other Clinical Trial Associates as needed.

Job Requirements

• Bachelor of Science (BS) in life sciences or equivalent experience required.
• Minimum of 4 years of experience in clinical research, preferably in oncology.
• Comprehensive knowledge of clinical trial regulations, including ICH-GCP and FDA guidelines.
• Proficiency in Microsoft Suite/Office, Adobe Acrobat, and eTMF platforms.
• Strong organizational, communication, and interpersonal skills.
• Ability to manage multiple projects and prioritize tasks effectively.
• Experience handling sensitive and confidential information with discretion.
• Familiarity with Smartsheet and other project management tools is preferred.