Sr. Clinical Research Associate (India)

2 hours, 2 minutes ago
Full-time
Senior
Operations
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 across one or more projects, including complex and multinational studies.
  • Oversee project monitoring services, including training, site and patient recruitment, data and document management, budgets, and regulatory filings in alignment with SOPs, study guidelines, and GCP best practices.
  • Serve as Lead CRA when assigned, acting as the primary liaison between CRAs and the project team.
  • Participate in the development of project plans, protocols, CRFs, communications, and other monitoring tools and documents.
  • Provide subject matter expertise, mentoring, coaching, and performance feedback to peers and managers as needed.
  • Assist with selection, hiring, training, and supervision of CRAs.
  • Conduct co-monitoring and training visits with CRAs.
  • Act as first escalation point for site and patient issues or sponsor concerns.
  • Represent the company in stakeholder relationships and at study team, kickoff, and investigator meetings.
  • Identify and recruit site investigators, coordinate delivery of trial materials, and support investigational site setup and communications.

Requirements

  • College diploma or degree required.
  • 4-6 years of related experience required.
  • Strong communication skills and self-motivation are required.
  • Strong attention to detail and critical thinking skills are required.
  • Ability to regularly travel to sites is required.
  • Experience working in clinical research site monitoring or site management is preferred.
  • Ability to build collaborative relationships with stakeholders is important.
  • Knowledge of SOPs, study guidelines, and GCP best practices is preferred.
  • Experience supporting site recruitment, regulatory filings, or project monitoring is preferred.

Benefits

  • Home-based remote work arrangement.
  • Regular travel required to support site monitoring activities.
  • Full-time, permanent employment.

Interested in this position?

Apply directly on the company website

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