Sr Clinical Research Associate 2 (CRA 2) Evergreen
IQVIA
Centurion, South Africa
1d ago

Job Overview

Perform monitoring and site management work for a variety of protocols, site and therapeutic areas.

Essential Functions

  • 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 / ICH 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.
  • Act as a mentor for clinical staff including conducting co-monitoring and training visits.
  • Collaborate and liaise with study team members for project execution support as appropriate.
  • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
  • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
  • Qualifications

  • Bachelor's Degree Degree in scientific discipline or health care preferred. Req
  • Requires at least 3 years of year of on-site monitoring experience.
  • Equivalent combination of education, training and experience may be accepted in lieu of degree.
  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Strong 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.
  • Report this job
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Apply
    My Email
    By clicking on "Continue", I give neuvoo consent to process my data and to send me email alerts, as detailed in neuvoo's Privacy Policy . I may withdraw my consent or unsubscribe at any time.
    Continue
    Application form