Clinical Trial Associate - TMF Veeva

Location: 100% remote - East Coast candidates strongly preferred.

• Decent experience in TMF QC and maintenance is going to be fairly important. Their TMF is in Veeva.
• There is a preference for candidates with both CRO and sponsor experience.

Position Description

The Clinical Trial Associate (Contractor) will support the Clinical Operations team in the execution and management of clinical trials. This individual will provide operational support across one or more clinical studies and may be responsible for managing selected trial-related activities. Working closely with Clinical Project Managers and Clinical Trial Managers, the Clinical Trial Associate will help ensure studies are conducted on schedule, within budget, and in compliance with applicable SOPs, FDA regulations, and ICH/GCP guidelines.

Responsibilities

• Maintain the Trial Master File (TMF) for assigned clinical studies, including the receipt, review, quality control, tracking, and filing of essential documents in accordance with company SOPs and regulatory requirements.
• Ensure assigned TMFs remain inspection-ready throughout the duration of the study.
• Prepare and communicate TMF metrics to internal stakeholders and external partners.
• Collaborate with cross-functional teams to support execution of the organization's TMF oversight strategy.
• Develop and maintain study tracking tools for patient recruitment, site activation, monitoring visits, and site payment activities.
• Support oversight of CROs and external vendors to help ensure successful execution of clinical trials, including participation in Clinical Trial Working Group meetings as appropriate.
• Review monitoring visit reports to support effective study oversight.
• Review site-specific informed consent forms for completeness and compliance.
• Track and manage site feasibility questionnaires.
• Assist with planning and coordination of Clinical Operations meetings and study-related events.
• Reconcile study invoices against contracts and budgets and support investigator site payment activities.
• Prepare and distribute study communications, including newsletters, updates, and other trial-related communications.
• Record, prepare, and distribute meeting agendas and minutes for assigned clinical studies.
• Partner with Clinical Trial Managers to prepare and maintain internal and external study documentation in accordance with study protocols, GCP, and applicable regulatory requirements.

Minimum Requirements

• Minimum of two years of experience working with Veeva Vault TMF.
• Two or more years of clinical operations experience, preferably including both sponsor and CRO environments.
• Working knowledge of FDA regulations, ICH/GCP guidelines, and Good Clinical Practice requirements.
• Experience collaborating with CROs and external vendors to support clinical trial execution.
• Proficiency with Veeva Vault TMF and Microsoft Office applications, including Word, Excel, PowerPoint, and Smartsheet.
• Ability to thrive in a fast-paced, dynamic environment with changing priorities.
• Strong organizational, time management, and attention-to-detail skills.
• Excellent written, verbal, and interpersonal communication skills.
• Bachelor's degree preferred, ideally in a life sciences, healthcare, or related discipline.