Senior Clinical Research Associate

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

📋 Description

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

• Train and manage site staff on therapeutic areas, protocol requirements, source documentation, and the completion of case report forms.

• Supervise and monitor investigational supplies at each site.

• Track and document the dispensing, inventory, and reconciliation of investigational products.

• Oversee and record the storage and shipment of laboratory samples.

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

• Assess source data and case report forms for accuracy, completeness, and integrity; identify and address any data issues.

• Examine data queries and listings, resolving discrepancies with study centers.

• Review regulatory documents and assist study centers with regulatory matters.

• Maintain comprehensive and accurate study files.

• Ensure timely communication with study centers, investigators, coordinators, client personnel, and other clinical trial stakeholders.

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

• Ensure that clinical trials adhere to protocols, SOPs, ICH GCP, and relevant regulatory requirements.

⛳️ Requirements

• RN or a 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 previous CRA experience reflecting career progression in the CRA role.

• Strong attention to detail.

• Exceptional organizational, interpersonal, communication, and problem-solving abilities.

• Adaptability to changing priorities.

• Capability to efficiently execute and prioritize multiple tasks.

• Knowledge of the medical and pharmaceutical sectors, including relevant terminology and practices.

• Comprehensive understanding of FDA regulations and their practical application.

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

• Proficiency in Microsoft Word, Excel, and PowerPoint.

• Ability to travel up to 65% of the time.

🏝️ Benefits

• Comprehensive medical, dental, and vision insurance options for you and your family.

• Flexible Paid Time Off (PTO).

• 401(k) plan with company matching.

• Support and opportunities for skill development and career progression.

• A collaborative community and a supportive work environment.