Job Title: Central Monitor
Location: Remote
Department: Clinical Services – Clinical Operations - Clinical Study Insights - Risk Management
Job Type: Full-time, Permanent, Remote
Salary Range: $75,000 - $124,000 per year
Accommodations for job applicants with disabilities are available upon request.
Company Overview:
Alimentiv is dedicated to advancing clinical research by providing expert services across clinical operations. This role will involve working on clinical research and non-interventional studies to ensure patient safety and data integrity.
Key Responsibilities:
Project Support
Protocol & Data Review:
Review and understand study protocols, data processes, safety, and data integrity risks.
Analyze patient data via dashboards and reports to identify eligibility, protocol deviations, safety concerns, data integrity issues, and other discrepancies.
Data Analysis & Risk Identification:
Assess site data quality, operational performance, and identify trends, risks, and issues affecting patient safety.
Utilize Key Risk Indicator (KRI) dashboards and analytical tools to synthesize data trends for operational follow-ups.
Monitoring & Reporting:
Perform remote data review in predefined time windows after data entry in the eCRF system.
Write queries, document observations, and propose action items based on findings.
Escalate serious issues to project teams, assisting in the development of action plans.
Collaboration & Communication:
Participate in investigator and sponsor meetings.
Attend and contribute to project team meetings and training sessions as per project-specific requirements.
Communicate issues and provide recommendations to the team and stakeholders.
Department Support
Process Improvement:
Contribute to the development, review, and implementation of central monitoring processes, policies, and associated documents.
Share insights for continuous improvement within the department and across the organization.
Mentorship & Training:
Provide coaching, mentorship, and training to peers and junior staff.
Lead initiatives for process improvement and knowledge sharing within the team.
Qualifications:
Education:
Minimum of a Bachelor’s degree.
Experience:
1-3 years of experience in Monitoring & Site Management or Clinical Data Management with a focus on Risk-Based Monitoring.
Strong knowledge of Good Clinical Practice (GCP) and ICH E6 (R2).
Technical Skills:
Proficiency in MS Office, with advanced skills in MS Excel.
Understanding of data analytics tools, statistical analysis techniques, and data visualizations.
Skills & Attributes:
Strong analytical, verbal, and written communication skills.
Ability to present, influence, and persuade effectively.
Excellent time management, organizational, and problem-solving skills.
Ability to work independently as well as cross-functionally in a global environment.
Working Conditions:
Location: Home-based.
Salary Range: $75,000 - $124,000 per year.
Remote Work: Yes, remote position with potential travel as needed.
How to Apply:
Interested candidates are encouraged to apply via the Alimentiv website.
Let me know if you need any further changes or additions!
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