Senior/Clinical Research Associate

6 hours, 50 minutes ago
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

  • Manage clinical trial site start-up, implementation, monitoring, and close-out activities.
  • Oversee site performance, patient safety, data quality, protocol compliance, and issue resolution.
  • Conduct qualification, initiation, routine monitoring, and close-out visits in accordance with ICH-GCP, local regulations, and company SOPs.
  • Prepare monitoring reports, follow-up documentation, tracking updates, and required study records.
  • Manage regulatory submissions, essential documents, informed consent processes, and Investigator Site File/Trial Master File reconciliation.
  • Review investigational product inventory, storage, dispensing, reconciliation, and related compliance requirements.
  • Perform EDC and patient profile reviews, resolve queries, and support clinical data quality activities.
  • Identify, escalate, and resolve site risks, protocol deviations, pharmacovigilance issues, and Serious Adverse Events.
  • Support investigator meetings, clinical training, protocol and study-document review, CRF development, and clinical study reports.
  • Mentor junior monitors, support project teams and clients, participate in proposals, and initiate investigator payments.

Requirements

  • Bachelor’s degree or international equivalent, ideally in business, science, healthcare, or a related discipline.
  • At least 3.5 years of on-site clinical monitoring experience.
  • Oncology experience and global clinical trial experience.
  • Working knowledge of the drug development process.
  • Proficiency with Microsoft Outlook, Word, Excel, and PowerPoint.
  • Fluent written and verbal English communication skills.
  • Strong attention to detail, accuracy, organization, teamwork, flexibility, and customer service orientation.
  • Ability to work efficiently in a remote environment (preferred).
  • Willingness to travel approximately 60–70%.
  • Legal authorization to work in the country of employment without employer sponsorship.

Interested in this position?

Apply directly on the company website

Apply Now

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