Senior CRA — Global Trial Monitoring & Data Quality

ProTrials Research, Inc.; United States; A distancia; USD 130.000 - 155.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, and vision insurance

Flexible PTO

401(k) with company match

Career growth opportunities

Collaborative team environment

Descripción de la vacante

ProTrials Research, Inc., a women-owned CRO, seeks a Senior Clinical Research Associate (Sr. CRA) to monitor and manage trials in line with protocol, SOPs, ICH GCP, and regulatory requirements. Travel up to 65% may be required.

You will train site staff, manage supplies, ensure data integrity, and maintain study documentation while collaborating with centers and project teams. An RN or Biology degree is preferred, with strong organization and communication skills.

Formación

• RN or Bachelor/advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training, and previous CRA experience demonstrating career growth in the CRA position
• Detail-oriented
• Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
• Flexibility with changing priorities

Responsabilidades

• Monitor clinical studies of investigational and approved products, including qualification, initiation, interim, and close-out site visits
• Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
• Manage and track the preparation and return of investigational supplies at individual sites
• Monitor and document investigational product dispensing, inventory, and reconciliation
• Monitor trial by reviewing site enrollment, monitoring visits, protocol deviations/exceptions, SAEs, and lab abnormalities
• Review source data and case report forms for accuracy, completeness, and data integrity, and resolve data issues
• Review data queries and listings, and work with study centers to resolve discrepancies
• Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues
• Maintain complete and accurate study files and review files to ensure documentation is present
• Maintain consistent contact with study centers, investigators, coordinators, client personnel, and others involved in trials
• Serve as a resource for project team members by supporting CRA I and II staff with solutions

Conocimientos

Clinical Monitoring

Site Training

Data Review

Regulatory Compliance

Educación

RN or Bachelor in Biological Sciences

Descripción del empleo

ProTrials Research, Inc., a women-owned CRO, seeks a Senior Clinical Research Associate (Sr. CRA) to monitor and manage trials in line with protocol, SOPs, ICH GCP, and regulatory requirements. Travel up to 65% may be required.

You will train site staff, manage supplies, ensure data integrity, and maintain study documentation while collaborating with centers and project teams. An RN or Biology degree is preferred, with strong organization and communication skills.