Sr. Clinical Research Associate (Poland)

2 months, 3 weeks ago
Full-time
Senior
Project and Program Management
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986

Description

  • Manage and deliver full clinical site monitoring services for one or more projects, including complex and multinational studies.
  • Design and oversee project monitoring services, including training, site and patient recruitment, data and document management, monitoring budgets, and regulatory filings.
  • Serve as the Lead CRA and primary liaison between CRAs and the project team.
  • Participate in the development of project plans, protocols, CRFs, communications, and other monitoring tools and documents as needed.
  • Act as a subject matter expert, mentor, and coach, and provide performance feedback to management for peers.
  • Assist with selection, hiring, training, and supervision of CRAs as needed.
  • Conduct co-monitoring and training visits with CRAs.
  • Act as the first escalation point for site and patient issues or sponsor concerns when required.
  • Manage monitoring services for groups of projects and/or CRAs on large or complex studies, including day-to-day direction and review of monitoring reports.
  • Participate in study team, kickoff, and investigator meetings and serve as the primary contact to sponsors for monitoring-related issues.

Requirements

  • College diploma or degree required.
  • 4-6 years of related experience required.
  • Strong communication skills and self-motivation.
  • Strong attention to detail and commitment to achieving positive results.
  • Critical thinking abilities.
  • Ability to build and maintain collaborative relationships with stakeholders.
  • Ability to regularly travel to study sites approximately 5-8+ days per month, depending on project and business needs.
  • Home-based position.
  • Experience supporting clinical site monitoring activities in alignment with SOPs, study guidelines, and GCP best practices.

Benefits

  • Home-based work arrangement.
  • Regular travel to study sites as part of the role.

Interested in this position?

Apply directly on the company website

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