Clinical Trial Associate, Senior Project Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the organization, updating, and maintenance of tracking systems and tools to facilitate the progress of clinical studies from initiation to conclusion.

• Aid in the coordination and creation of study management tools, monitoring instruments, study manuals, training materials, and presentations.

• Schedule meetings, prepare and circulate meeting agendas, minutes, and follow-up action items for study teams.

• Establish, organize, and maintain study files and shared spaces in alignment with study requirements.

• Coordinate and monitor study training sessions.

• Oversee study sample and supply tracking, and assist with vendor interactions as necessary.

• Provide support to the Study Management team on specific projects.

• Communicate with members of the study team to identify and resolve study-related issues in collaboration with the team.

• Conduct routine quality checks on trial-level documents to ensure their completeness and accuracy.

• Assist in the timely, complete, and compliant archiving of documents in the TMF.

• Participate in company, departmental, and project team meetings, including Investigator Meetings.

• Support basic financial and budget tracking activities related to the clinical trial.

⛳️ Requirements

• A BS/BA degree or a degree in a healthcare field is required.

• At least 1 year of experience supporting clinical operations activities in a similar role within a pharma or biotech organization, or 2 years of experience in a CRO environment.

• Basic understanding of drug development and clinical operations processes.

• Foundational knowledge of the clinical trial process and support for study activities in compliance with ICH-GCP and the Code of Federal Regulations.

• Strong written and verbal communication skills, with the ability to collaborate effectively within study teams.

• Excellent organizational and interpersonal skills.

• Foundational experience with eTMF systems (preferably VeevaVault) and basic knowledge of essential documents for accurate filing of study documents under guidance.

• High attention to detail.

• Ability to prioritize and manage multiple tasks with competing deadlines.

• A strong sense of urgency and commitment to excellence in the successful execution of deliverables.

• Demonstrates the ability to identify issues and escalate them appropriately to maintain timeline adherence.

• Proficient in MS Office Suite (Excel, Word, PowerPoint) and project tracking tools.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Flexible work environment with a focus on work-life balance.

• Supportive team culture and collaborative work environment.