Senior Clinical Research Associate

1 hour, 54 minutes ago
Full-time
Senior
Project and Program Management
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 all aspects of clinical study site management to protect patient safety and maintain data quality.
  • Lead site start-up activities, including feasibility, investigator recruitment, EC/IRB submissions, and regulatory document collection and review.
  • 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, communication logs, and other required study documentation.
  • Review Investigator Site Files and reconcile them with the Trial Master File to ensure completeness and archive readiness.
  • Support patient recruitment, retention, awareness strategies, and informed consent process verification.
  • Perform investigational product inventory, reconciliation, storage, security, labeling, import, release, and return oversight.
  • Review remote EDC CRFs and patient profiles, resolve queries, and support data discrepancy resolution with data management teams.
  • Identify, document, and escalate site risks, protocol deviations, pharmacovigilance issues, and Serious Adverse Events.
  • Mentor and train junior monitors, support project managers and clinical trial managers, and contribute to study documents, presentations, and client interactions.

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 3.5 years of on-site monitoring experience.
  • Oncology experience is required.
  • Experience with global clinical trials.
  • High proficiency in Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
  • Fluency in English, both verbal and written.
  • Working knowledge of the drug development process.
  • Ability to demonstrate flexibility, teamwork, strong attention to detail, and high accuracy.
  • Travel required 60-70%.
  • Solid clinical research or related experience is preferred.
  • Excellent organizational skills are preferred.
  • Ability to work efficiently in a remote work environment is preferred.

Interested in this position?

Apply directly on the company website

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