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Senior/Clinical Research Associate

2 hours, 16 minutes ago
Taiwan
Full-time
Junior
Project Manager
Project and Program Management
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 132

Description

  • Oversee site management to protect patient safety and maintain high-quality study data with low query levels.
  • Provide site- and project-level guidance to support audit readiness and follow-up actions.
  • Update, track, and maintain study management tools, systems, and status reports.
  • Manage site start-up activities when required, including feasibility, investigator recruitment, IRB/EC submissions, and regulatory document review.
  • Assist with study budget negotiation and investigator contract execution when required.
  • Verify informed consent documentation and assess factors affecting subject safety and data integrity.
  • Conduct pre-study, initiation, routine monitoring, and close-out visits on-site and remotely.
  • Prepare and submit accurate monitoring reports, follow-up letters, trip reports, and communication logs.
  • Support subject recruitment, retention, and awareness efforts, and enter tracking data to close action items.
  • Review ISF and TMF completeness, reconcile essential documents, and ensure proper site archiving.
  • Communicate protocol issues, deviations, and corrective actions with site personnel and internal study teams.
  • Perform investigational product inventory, reconciliation, storage, security, labeling, import, release, and return oversight.
  • Review remote EDC/CRF and patient data, resolve queries, and support data quality issue resolution.
  • Identify and process serious adverse events and follow study SAE reporting procedures.
  • Identify site risks, escalate them with proposed contingencies, and drive timely resolution.
  • Attend investigator meetings, sponsor meetings, global monitoring meetings, and clinical training sessions.
  • Travel as needed for project requirements.

Requirements

  • Bachelor's degree or international equivalent, or equivalent combination of education and experience, ideally in a business, scientific, or healthcare discipline.
  • Minimum of 2 years of on-site monitoring experience for CRA II level candidates.
  • 1 year of oncology and Phase I experience preferred.
  • High proficiency with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
  • Ability to work with strong attention to detail and accuracy for extended periods.
  • Fluency in English, both written and verbal.
  • Working knowledge of the drug development process.
  • Travel required at 60-70%.
  • Solid experience in clinical research or related experience preferred.
  • Excellent organizational skills preferred.
  • Ability to work efficiently in a remote work environment preferred.
  • Good knowledge and use of ICH-GCP, Precision SOPs, and regulatory guidance.
  • Strong interpersonal, written, verbal, and presentation skills.
  • Ability to work independently, plan effectively, and collaborate in a team environment.
  • Self-motivated, detail-oriented, and able to deliver on commitments.

Benefits

  • Work on groundbreaking cancer therapies in oncology and rare disease.
  • Opportunity to contribute ideas and have them valued and nurtured.
  • A culture that emphasizes employee appreciation and positive impact.
  • Equal opportunity employment practices.
  • Reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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