Clinical Trial Assistant

Job Purpose

The Clinical Trial Assistant will provide essential administrative support to the Clinical team, aiding in the day-to-day operations of clinical studies. This role requires a foundational understanding of clinical trials, exceptional organizational capabilities, and the ability to thrive in a fast-paced, dynamic setting.

Responsibilities

• Support team members with administrative tasks crucial for clinical trial execution and management.
• Monitor study progress to ensure all study files are current, accurate, and compliant with local regulatory requirements and ICH/GCP guidelines.
• Aid in the creation of study start-up materials and provide support for feasibility study activities.
• Contribute to the design and implementation of Case Report Forms (CRF), completion guidelines, and database testing.
• Manage clinical study schedules and collaborate with the study team on subject tracking to maintain protocol adherence.
• Organize and maintain publication libraries, clinical study documents, and reference materials.
• Assist Clinical Research Associates (CRAs) and management in resolving study-related issues.
• Review data within Electronic Data Capture (EDC) and file management systems, generate data downloads and reports, and compile summaries of data extractions for review.
• Collaborate with CRAs, Data Management, and vendors to ensure data cleaning, tracking, and analysis quality.
• Assist in the preparation of presentations for project, departmental, or business development needs.
• Manage the ordering and inventory of ancillary clinical study supplies.
• Support the preparation, shipping, handling, distribution, and accountability of clinical trial supplies.
• Contribute to the development of best practices and Standard Operating Procedures (SOPs) for clinical trial management.
• Stay informed about current regulations and guidelines to ensure ongoing compliance.
• Resolve routine problems of limited scope and complexity according to established policies.
• Work collaboratively with the team to address more complex issues.
• Perform other duties as assigned.

Requirements

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Adobe, and web conferencing tools. Familiarity with relational databases is a plus.
• Basic understanding of clinical trial regulations and guidelines, including GCPs and ICH guidelines.
• Exceptional organizational skills, with the ability to manage multiple tasks simultaneously and a keen eye for detail.

Qualifications

A Bachelor's degree or equivalent experience is preferred. Strong communication, teamwork, organizational, interpersonal, and problem-solving skills are essential.

Working Conditions

This role operates within an Office and Laboratory Environment. Occasional travel, up to 15% of the time, may be required.

Physical Requirements

Employees are regularly required to sit for extended periods. There may be occasional requirements to lift or move up to 20 pounds.

Additional Information

No direct reports. Management reserves the right to assign or reassign duties and responsibilities at any time.