Research Associate

7 days ago

Beijing, Beijing, China IQVIA Full time
Job Description

This is a Senior Research Associate position with the responsibility of conducting site management and monitoring work to ensure that sites are conducting studies and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Key Responsibilities
  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
  • 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.
  • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
  • 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.
  • Collaborate and liaise with study team members for project execution support as appropriate.
Requirements
  • Bachelor's Degree in scientific discipline or health care preferred.
  • Requires at least 1 year of on-site monitoring experience.
  • Equivalent combination of education, training and experience may be accepted in lieu of degree.
  • 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.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Compensation and Benefits

The salary for this role is estimated to be around $80,000 - $100,000 per annum, depending on location and experience. IQVIA offers a range of benefits, including health insurance, retirement savings plan, paid time off, and opportunities for career growth and development.

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