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Clinical Research Associate Lead

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Primary Location: Petaling Jaya, Selangor, Malaysia Full time R1232544

Job description

Essential Functions

  • Provide clinical research training for junior CRAs.
  • Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. If applicable, Clinical Research Associates may be accountable for development of project subject recruitment plan on a per site basis. Support work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
  • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  • Build awareness of features and opportunities of study to site.
  • Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications

  • Bachelor's Degree Bachelor's degree or educational equivalent
  • Adequate knowledge and experience in clinical trials;
  • Minimum of 4 years of on-site monitoring experience;
  • Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Strong knowledge of organizational development principles and methods
  • Strong interpersonal, project management, organizational and leadership skills
  • Strong verbal and written communication skills
  • Excellent presentation skills
  • Strong coaching and counseling skills
  • Strong problem solving and critical thinking skills
  • Strong listening and diagnostic skills

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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