Senior Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee clinical studies of investigational and approved products that meet a medical need and/or provide a commercial advantage, encompassing qualification, initiation, interim, and close-out site visits.

• Supervise and train site personnel on therapeutic areas, protocol specifications, proper source documentation, and the completion of case report forms.

• Manage and monitor the preparation and return of investigational supplies at each site.

• Oversee and record the dispensing, inventory, and reconciliation of investigational products.

• Track and document the storage and shipment of laboratory samples.

• Review and report on trial progress, including site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities.

• Evaluate source data and case report forms for accuracy, completeness, and data integrity, while identifying and addressing ongoing data issues.

• Analyze data queries and listings, collaborating with study centers to resolve any data discrepancies.

• Inspect regulatory documentation for accuracy and completeness, providing support to study centers with regulatory matters.

• Maintain comprehensive and precise study files, reviewing them to ensure all necessary documentation is included.

• Ensure consistent and timely communication with study centers, investigators, coordinators, client personnel, and other parties involved in clinical trials.

• Act as a resource for project team members, including assisting CRA I and CRA II staff by offering solutions to resolve issues.

⛳️ Requirements

• RN or Bachelor’s and/or advanced degree in biological sciences or a related field, or an equivalent combination of relevant experience, education, or training, along with prior CRA experience demonstrating career progression in the CRA role.

• Strong attention to detail.

• Exceptional organizational abilities, strong interpersonal and communication skills, and solid problem-solving capabilities.

• Adaptability to shifting priorities.

• Capacity to efficiently perform and prioritize multiple tasks.

• Familiarity with the medical and pharmaceutical sectors, including related terminology and practices.

• Extensive understanding of FDA regulations and their practical application.

• Willingness to travel, including by air or car, on short notice.

• Proficient in Microsoft Word, Excel, and PowerPoint.

🏝️ Benefits

• Equal opportunity employer.

• Workplace free from discrimination and harassment.

• Collaborative community dedicated to making a significant impact on global health.