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Clinical Research Associate II (Poland)

1 week, 3 days ago
Poland
Full-time
Junior
Operations Specialist
Operations
Apply Now
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
View All Jobs 39

Description

  • Conduct remote and onsite site monitoring activities, including feasibility, qualification, initiation, monitoring, and close-out visits under supervision and/or independently.
  • Document site contacts and monitoring activities in accordance with SOPs and study guidance.
  • Perform remote review of EDC, CTMS, RBM, and other clinical systems to support data review and site oversight.
  • Identify trends across study sites and escalate issues appropriately.
  • Review the site section of the TMF for accuracy, timeliness, and completeness.
  • Support resolution of data queries, safety review findings, adverse events, and other data management issues.
  • Coordinate site communications with project teams to ensure investigational sites receive accurate updates and regulatory guidance.
  • Support audit preparation and follow-up actions.
  • Assist senior CRAs and lead CRAs with day-to-day study management activities.
  • Participate in study trainings, team meetings, and ongoing study team updates.

Requirements

  • Minimum of a college diploma or degree.
  • 1-3 years of related experience.
  • SoCRA, CCRA, and/or ACRP certification/designation is an asset.
  • Self-motivated with strong communication skills and a commitment to achieving positive results.
  • Strong attention to detail.
  • Ability to build collaborative relationships to achieve results.
  • Commitment to continuous learning and self-development.
  • Ability to foster teamwork.
  • Home-based role with regular travel.
  • Experience working to ICH GCP, SOP, sponsor, and regulatory standards is required or strongly implied by the role.

Benefits

  • Full-time, permanent position.
  • Remote / home-based work within Poland.
  • Regular travel included in the role.
  • Training and development focus with a structured CRA development track.
  • Exposure and training across all aspects of clinical site monitoring services.
  • Opportunity to develop CRA competencies through supervised and independent work.

Interested in this position?

Apply directly on the company website

Apply Now

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