Senior/Clinical Research Associate

20 hours, 18 minutes ago
Full-time
Senior
Operations
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised

Description

  • Oversee study site management to protect patient safety and maintain data quality across assigned studies.
  • Serve as the primary point of contact for study sites and communicate protocol or site issues to project leadership.
  • Conduct pre-study, initiation, routine monitoring, and close-out visits in accordance with protocol, local laws, ICH-GCP, and company SOPs.
  • Prepare, submit, and maintain accurate monitoring reports, follow-up letters, trip reports, communication logs, and other required study documents.
  • Support site startup activities, including feasibility, investigator recruitment, EC/IRB submissions, and regulatory document collection and review.
  • Assist with study budget negotiations and investigator contract execution when needed.
  • Review informed consent documentation, site files, and trial master file records for accuracy, completeness, and compliance.
  • Perform investigational product inventory, reconciliation, storage, labeling, import, release, and return oversight.
  • Review EDC/CRF data, resolve queries, and support resolution of data discrepancies with data management teams.
  • Identify, process, and escalate site risks, protocol deviations, serious adverse events, and other quality issues, and drive timely resolution.

Requirements

  • Bachelor's degree or international equivalent, or an equivalent combination of education and experience, ideally in a business, scientific, or healthcare discipline.
  • Minimum of 2 years of on-site monitoring experience.
  • At least 1 year of oncology experience.
  • Global clinical trial experience.
  • High proficiency with Microsoft Office (Outlook, Word, Excel, and PowerPoint).
  • Strong English communication skills, both verbal and written.
  • Working knowledge of the drug development process.
  • Ability to maintain high attention to detail and accuracy for extended periods.
  • Customer service-oriented mindset with flexibility and teamwork.
  • Ability to travel 60-70% of the time.
  • Solid experience in clinical research or related experience (preferred).
  • Excellent organizational skills (preferred).
  • Ability to work efficiently in a remote work environment (preferred).

Interested in this position?

Apply directly on the company website

Apply Now

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