Lead Clinical Research Associate - Contract Role

Lever, Inc.; United States; Hybrid; USD 110,000 - 160,000; Full time

Job summary

ProTrials is seeking a Contract Lead Clinical Research Associate to oversee a CRA team and support CTAs in studies across the clinical research lifecycle. You will ensure timely initiation, enrollment, conduct, and completion while maintaining quality and regulatory compliance.

Responsibilities include leading CRA teams, developing monitoring plans, overseeing TMF/eTMF, and coordinating with sites, vendors, and clients. Travel for on-site and remote monitoring is expected.

Qualifications

• RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent experience.
• Previous CRA experience preferred.
• Strong communication, organization, prioritization, presentation, discretion, and accuracy.

Responsibilities

• Provide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study.
• Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with SOPs, regulations, GCP, KPIs, and study-specific requirements.
• Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals; review data reports, CTMS, and site communications; resolve data discrepancies.
• Create annotated visit report templates and other documents related to site management and monitoring.
• Support training and development of team members; ensure training requirements are met and documented.
• Guide CRAs, CTAs, and CROs regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters per SOPs.
• Manage TMF/eTMF oversight and assist with filing and quality control.
• Track SAEs, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and product; review with study team.

Skills

Communication

Organization

Prioritization

Presentation

Discretion

Accuracy

Problem solving

Travel readiness

MS Office

Education

RN, Bachelor, or advanced degree in biological sciences

Tools

Microsoft Word

Excel

PowerPoint

Job description

ProTrials is seeking a Contract Lead Clinical Research Associate to oversee a CRA team and support CTAs in studies across the clinical research lifecycle. You will ensure timely initiation, enrollment, conduct, and completion while maintaining quality and regulatory compliance.

Responsibilities include leading CRA teams, developing monitoring plans, overseeing TMF/eTMF, and coordinating with sites, vendors, and clients. Travel for on-site and remote monitoring is expected.