Senior Clinical Research Associate – Contract Position

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

📋 Description

• Oversee clinical trials for investigational and approved products, including qualification, initiation, interim, and close-out site visits.

• Train and manage site personnel regarding therapeutic areas, protocol specifications, source documentation, and the completion of case report forms.

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

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

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

• Monitor and report updates on site enrollment and terminations, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory irregularities.

• Review source data and case report forms for accuracy, completeness, and integrity; identify and rectify data discrepancies.

• Examine data queries and listings and collaborate with study centers to address discrepancies.

• Assess regulatory documentation and assist study centers with regulatory matters.

• Ensure that study files are complete and accurate, verifying all required documentation.

• Maintain prompt communication with study centers, investigators, coordinators, client personnel, and other stakeholders in clinical trials.

• Provide support to CRA I and CRA II staff by offering solutions to resolve issues.

⛳️ Requirements

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

• Strong attention to detail.

• Excellent organizational abilities, strong interpersonal and communication skills, and effective problem-solving capabilities.

• Adaptability to changing priorities.

• Capacity to efficiently perform and prioritize multiple tasks.

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

• Comprehensive knowledge of FDA regulations and their practical application.

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

• Proficiency in Microsoft Word, Excel, and PowerPoint.

🏝️ Benefits

• Equal opportunity employer dedicated to maintaining a workplace free from discrimination and harassment.