Clinical Site Monitor (Lead CRA)

Location: Home-based
Travel: Regular travel required
Salary: $58,000 - $96,500 per year

About Alimentiv:
Alimentiv is a global organization focused on clinical research. The company uses artificial intelligence (AI) tools to assist in the hiring process, but final decisions are made by humans.

Role Overview:
Manage, deliver, and/or perform full clinical site monitoring services for one or more complex, potentially multinational projects. This in-house based position is responsible for the design and oversight of monitoring services, including training, site/patient recruitment, data/document management, site budgets, and regulatory filings, all in alignment with SOPs, study guidelines, and GCP best practices. As a Lead CRA, you will act as the primary liaison between CRAs and the project team, potentially contributing to project plans, protocols, and other monitoring documents.

Monitoring - Subject Matter Expert:

• Act as a subject matter expert, mentor, coach, and provide performance feedback to managers for peers.
• Assist with the selection, hiring, training, and supervision of CRAs; perform co-monitoring and training visits.
• Serve as the first escalation point for site/patient issues or sponsor concerns.
• May represent Director or Manager in Business Development initiatives with a site monitoring focus.

Project Monitoring Lead:

• May manage monitoring services for a group of projects and/or CRAs on large/complex projects, directing day-to-day activities and reviewing monitoring reports.
• Function as a liaison between CRAs and other functional teams, escalating concerns to management.
• Participate and/or present at study team, kickoff, and investigator meetings.
• Act as the primary contact for sponsors regarding all monitoring-related issues.

Site Recruitment and Setup:

• Identify and recruit site investigators.
• Coordinate the movement and delivery of trial materials, samples, tests, and forms, including investigational product, protocols, SOPs, CRFs, and support tools.
• Ensure SOPs are in place to optimize patient recruitment and provide guidance on inclusion/exclusion criteria.

Investigational Site Monitoring:

• Serve as the primary clinical site contact for questions or issues.
• Oversee study integrity and foster positive working relationships with sites and staff.
• Facilitate site staff access to study systems and ensure compliance with project-specific training.
• Ensure all site-related issues are resolved.
• Coordinate clinical site communications, ensuring sites receive accurate ongoing data, updates, and feedback.

Qualifications:

• Minimum of a college diploma/degree and 4-6 years of related experience.
• Self-motivation with strong communication skills and a commitment to achieving positive results.
• Strong attention to detail and keenness to build collaborative relationships.
• Ability to engage in continuous learning and self-development.
• Ability to foster teamwork.
• For positions supporting Flemish sites in Belgium, Dutch language skills are required.