Senior CRA Lead: Clinical Trial Oversight & Strategy

OpenKrill; United States; Ibrido; USD 110.000 - 170.000; Tempo pieno

Descrizione del lavoro

ProTrials is seeking a Contract Lead Clinical Research Associate to guide the CRA team and provide direction across studies. The role ensures initiation, enrollment, conduct, and completion with strong project management support and resource planning.

You will monitor adherence to SOPs, regulations, and GCP while developing clinical plans and study timelines, and coordinating with sites and vendors. Travel and remote monitoring are part of the role, with a focus on quality and compliance.

Competenze

• RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent experience.
• Previous CRA experience preferred.
• Extensive knowledge of FDA regulations and practical implementation.
• Willingness to travel and perform remote and on-site monitoring as needed.
• Proficient with SOPs, data handling, and study timelines.

Mansioni

• Provide study oversight as the primary liaison between CRAs, staff, investigators, and vendors.
• Ensure monitoring activities comply with SOPs, regulations, and GCP.
• Develop and manage clinical plans, timelines, and data reviews.
• Create visit report templates and site management strategies.
• Support training and documentation for the team.
• Guide CRAs, CTAs, and vendors on monitoring, co-monitoring, and audits.
• Oversee TMF/eTMF filing and quality control.
• Track SAEs, protocol deviations, enrollments, and investigational products.

Conoscenze

Communication

Organization

Prioritization

Presentation

Discretion

Accuracy

Formazione

Nursing RN or Bachelor's or higher in biological sciences

Strumenti

Microsoft Word

Microsoft Excel

PowerPoint

Descrizione del lavoro

ProTrials is seeking a Contract Lead Clinical Research Associate to guide the CRA team and provide direction across studies. The role ensures initiation, enrollment, conduct, and completion with strong project management support and resource planning.

You will monitor adherence to SOPs, regulations, and GCP while developing clinical plans and study timelines, and coordinating with sites and vendors. Travel and remote monitoring are part of the role, with a focus on quality and compliance.