Sr. Clinical Research Associate (US)

3 hours, 21 minutes 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

  • Independently conduct and document onsite and remote site monitoring, qualification, initiation, and close-out visits.
  • Review source documents and study system data to ensure consistency, accuracy, and compliance with study requirements.
  • Monitor, resolve, and escalate data queries, site issues, protocol deviations, and action items through resolution.
  • Coordinate clinical supply shipments, including investigational product, laboratory supplies, ePROs, and study documents.
  • Train site staff on the protocol, study plans, systems, and ICH-GCP requirements.
  • Serve as the primary contact for investigational site questions and support strong working relationships with site and study teams.
  • Review ISF and TMF for accuracy, timeliness, and completeness, and request missing documents as needed.
  • Coordinate site communications and support site activation, recruitment, and milestone execution.
  • Participate in audits, inspections, study progress meetings, teleconferences, and Investigator meetings.
  • Mentor CRA I and II staff and support internal process improvement initiatives.

Requirements

  • College diploma or degree.
  • 4-6 years of related experience.
  • Ability to regularly travel to sites.
  • Ability to travel up to 40-60% depending on project assignment and site location.
  • Experience using EDC systems such as Medidata Rave or Oracle InForm.
  • Experience with IRT, eTMF, CTMS, and Microsoft Office Suite.
  • Strong interpersonal and problem-solving skills.
  • Ability to work independently and within cross-functional teams.
  • Strong communication, organizational, detail-oriented, and sense-of-urgency skills.

Benefits

  • Home-based work arrangement.
  • Regular travel required.

Interested in this position?

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