Clinical Research Associate I

3 weeks ago

Beijing, Beijing, China Parexel Full time

Job Summary:

Parexel is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for ensuring the quality and integrity of clinical trials from site identification through close-out.

Key Responsibilities:

  • Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
  • Build relationships with investigators and site staff.
  • Conduct, drive and manage country-specific feasibility and/or site pre-qualification and qualification activities.
  • Generate visit/contact reports, using judgment to identify site issues and problem-solving to direct resolution.
  • Develop strategy to configure, distribute, and collect, and review and approve, high-quality country-specific and/or site-specific documents or essential regulatory documents.
  • Customize, review, and negotiate as needed, country/site-specific Informed Consent Forms (ICF), translations, and customize and negotiate any amendments.
  • Prepare and submit IRB/IEC and MoH/RA application(s), resolving conflicts, determining appropriate follow-up until receipt of final approval.
  • Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
  • Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH/RA submission/approval, site activation, and patient recruitment & retention.
  • Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
  • Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue.
  • Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project-specific training requirements prior to study start.
  • Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
  • Work in a self-driven capacity, with limited need for oversight.
  • Proactively keep manager informed about work progress and any issues.

Requirements:

  • Previous relevant work experience preferred.
  • Education to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.

What We Offer:

Parexel offers a competitive salary and benefits package, as well as opportunities for professional growth and development.

How to Apply:

If you are a motivated and detail-oriented individual with a passion for clinical research, please submit your application, including your resume and cover letter, to [insert contact information].

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