Senior Clinical Research Associate

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

📋 Description

• Oversee clinical studies for both investigational and approved products through the processes of qualification, initiation, interim assessments, and site closure visits.

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

• Administer and monitor investigational supplies at various sites.

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

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

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

• Assess source data and case report forms for precision, completeness, and data integrity; pinpoint and address data discrepancies.

• Analyze data queries and listings, resolving inconsistencies with study centers.

• Examine regulatory documentation and assist study centers with regulatory challenges.

• Ensure the maintenance of thorough and accurate study files.

• Sustain timely 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 address issues.

• Guarantee that clinical trials adhere to protocols, SOPs, ICH GCP, and relevant regulatory standards.

• Willingness to travel up to 65% as necessary.

⛳️ 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.

• Prior CRA experience reflecting professional advancement in the CRA role.

• Strong attention to detail.

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

• Adaptability to shifting priorities.

• Capacity to efficiently manage and prioritize multiple tasks.

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

• In-depth 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

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

• Flexible paid time off (PTO).

• 401(k) plan with company matching.

• Support for professional growth and career development opportunities.

• A collaborative work environment with supportive coworkers.