Clinical Trial Associate

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

📋 Description

• Provide assistance in organizing, updating, and maintaining tracking systems and tools that support clinical studies from initiation to closure.

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

• Schedule meetings and prepare, distribute, and follow up on agendas, minutes, and action items for study teams.

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

• Coordinate and monitor study training initiatives.

• Oversee tracking of study samples and supplies, and facilitate interactions with vendors.

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

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

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

• Assist with the timely, complete, and compliant archiving of the Trial Master File (TMF).

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

• Support basic financial and budget tracking activities associated with the clinical trial.

⛳️ Requirements

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

• A minimum of 1 year of experience in a similar role supporting clinical operations in a pharma or biotech organization, or 2 years 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 accordance 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 needed to accurately file study documents with guidance.

• High attention to detail.

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

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

• Demonstrated ability to identify issues and escalate them appropriately to support adherence to timelines.

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

• Candidates must be based on the East Coast of the US.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Supportive and collaborative work environment.

• Flexible work arrangements.