IQVIA

Senior Clinical Research Associate

IQVIA

full-time

Posted on:

Location Type: Office

Location: Sydney • Australia

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required.
  • Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements.
  • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol.
  • Escalate quality issues as appropriate.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals.
  • Ensure copies/originals of site documents are available for filing in the Trial Master File (TMF).

Requirements

  • Bachelor's Degree in scientific discipline or health care.
  • Requires at least 1 year of on-site monitoring experience.
  • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
  • Good therapeutic and protocol knowledge as provided in company training.
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
  • Written and verbal communication skills including good command of English language.
  • Organizational and problem-solving skills.
  • Effective time and financial management skills.
Benefits
  • IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.
  • All information and credentials submitted in your application must be truthful and complete.
  • Any false statements will result in immediate disqualification.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
on-site monitoringclinical research regulatory requirementsGood Clinical Practice (GCP)International Conference on Harmonization (ICH) guidelinestherapeutic knowledgeprotocol knowledge
Soft Skills
written communicationverbal communicationorganizational skillsproblem-solving skillstime managementfinancial management