Lead Clinical Research Associate - Team & Trials Leader

ProTrials Research, Inc.; United States; Remote; USD 135,000 - 159,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Flexible PTO

401(k) with company match

Career growth opportunities

Positive team culture

Job summary

ProTrials Research, Inc. is seeking a Lead Clinical Research Associate (LCRA) to direct and mentor the CRA/CTA team across multiple studies. You will ensure timely initiation, enrollment, conduct, and completion, while providing project management support and resource oversight.

The role requires strong leadership, SOP/compliance adherence, and proactive issue resolution to maintain high-quality trials. Expect travel and on-site/remote monitoring as needed; a biological sciences degree or CRA

Qualifications

• Requires RN, Bachelor or advanced degree in biological sciences or related field, or equivalent combination of education/experience.
• Previous CRA experience preferred.
• Excellent communication, organization, prioritization, presentation, discretion and accuracy are essential.
• Familiarity with FDA regulations and practices is required.
• Willingness to travel and perform remote and on-site monitoring as needed.

Responsibilities

• Provide study oversight as the primary liaison between CRAs, internal staff, site staff including investigators, coordinators, client personnel, and external vendors.
• Ensure monitoring activities are performed per SOPs, regulations, GCP, KPIs and project requirements.
• Develop and manage clinical plans and guidelines, including monitoring plans and study timelines; ensure compliance and resolve data discrepancies.
• Create visit report templates and other site management/monitoring documents and strategies.
• Support training and development of team members with proper documentation.
• Guide CRAs, CTAs, and CROs on monitoring, co-monitoring, training, and audit visits; review site visit reports and letters.
• Oversee TMF/eTMF and assist with filing and quality control.
• Track SAE, protocol deviations, enrollment, ICFs, and investigational supplies; review with study team.
• Perform qualification, initiation, interim, and close-out visits and provide reports as needed.

Skills

Communication

Organization

Prioritization

Presentation

Discretion

Accuracy

Solutions-oriented

FDA knowledge

MS Office

Travel flexibility

Education

Biological sciences degree or RN or advanced degree

Tools

Microsoft Word

Excel

PowerPoint

Job description

ProTrials Research, Inc. is seeking a Lead Clinical Research Associate (LCRA) to direct and mentor the CRA/CTA team across multiple studies. You will ensure timely initiation, enrollment, conduct, and completion, while providing project management support and resource oversight.

The role requires strong leadership, SOP/compliance adherence, and proactive issue resolution to maintain high-quality trials. Expect travel and on-site/remote monitoring as needed; a biological sciences degree or CRA