Lead Clinical Research Associate

Responsibilities

• Provide study oversight as the primary liaison between CRAs, internal staff, study site staff, client personnel, and external vendors
• Ensure clinical monitoring activities are performed in accordance with SOPs, regulations, and good clinical practices
• Develop, review, and manage clinical plans, monitoring plans, and study timelines
• Create annotated visit report templates and site management strategies
• Support training and development of team members and ensure compliance with training requirements
• Guide CRAs, CTAs, and external CROs regarding monitoring, co-monitoring, and audit visits
• Manage oversight of the Trial Master File (TMF)/eTMF and assist with quality control
• Track serious adverse events, protocol deviations, enrollment, and investigational products
• Perform qualification, initiation, interim, and close out visits as needed

Requirements

• RN, Bachelor, or advanced degree in biological sciences or related field
• Previous CRA experience preferred
• Extensive knowledge of FDA regulations and practical implementation
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Willingness to travel for remote and on-site monitoring
• Strong communication, organization, and problem-solving skills

About the Company

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting the pharmaceutical, biotech, and medical device industries.