Senior Clinical Research Associate/ Clinical Research Associate
IQVIA
Makati City, Philippines
1d ago

Responsibilities :

  • 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.
  • Requirements :

  • Bachelor's degree in a health care or other scientific discipline or educational equivalent.
  • Minimum of 1+ years of on-site monitoring experience; or equivalent combination of education, training and experience.
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
  • Good written and verbal communication skills
  • Good organizational and problem-solving skills
  • Effective time management skills
  • C1920

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