Senior Clinical Research Associate

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

📋 Description

• Conduct clinical trial monitoring activities, which include monitoring, reporting, and tracking the progress of studies.

• Examine Investigator Site Files to ensure accuracy and prompt reporting to the central Trial Master File repository.

• Evaluate clinical trial adherence to regulatory standards, protocols, monitoring plans, and SOPs.

• Engage with sponsors, investigational sites, vendors, and various Everest functional groups.

• Identify potential clinical trial sites and conduct feasibility and Pre-Study Visits.

• Participate in Investigator Meetings and training sessions for CRAs/Study Coordinators.

• Support sites with inquiries related to the study.

• Provide insights on study manuals, case report form guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools.

• Conduct Site Initiation, Interim Monitoring, and Close-Out Visits.

• Submit Monitoring Visit Reports and follow-up letters via the Clinical Trial Management System.

• Assist with precept/oversight visits and review/approve CRA I/II monitoring visit reports.

• Review and reconcile Investigator Site Files and Trial Master Files.

• Ensure that sites submit the necessary documents to Institutional Review Boards/Ethics Committees.

• Keep ISF/TMF in a state that is ready for inspection.

• Establish communication channels and provide ongoing protocol/study-related training to assigned sites.

• Ensure a continuous flow of data, including site data entry, query resolution, and source document verification.

• Evaluate patient recruitment and retention and recommend enhancements.

• Ensure the proper management and reconciliation of investigational products, medical devices, and clinical trial supplies.

• Prepare sites for inspections or audits from regulatory bodies, sponsors, or CROs.

• Submit accurate and timely expense reports.

• Assist with Requests for Proposals and bid defenses.

• Support Clinical Operations with related tasks as required.

• Plan and implement professional development initiatives.

⛳️ Requirements

• Bachelor’s degree in a life science or a related field of study.

• At least six (6) years of monitoring experience.

• In-depth knowledge of ICH-GCP guidelines and relevant regulations.

• Strong understanding of medical terminology.

• Exceptional organization and communication skills, both verbal and written.

• Willingness to travel up to 70% of working hours to various locations nationwide.

• Must possess a valid driver’s license and be capable of driving to monitor sites.

🏝️ Benefits

• Equal opportunity employer.

• Accommodations for candidates participating in any phase of the recruitment and selection process.

• Opportunities for professional development and planning.

• Flexible remote work arrangements.

• Reduced travel hours may apply for projects involving remote or virtual visits.