Clinical Research Associate (Sponsor Dedicated) - Home Based in South Africa
Discover a career with greater purpose!
As a Clinical Research Associate at IQVIA, you will work as part of our single sponsor program dedicated to a key pharmaceutical client.
Join us and benefit from what we offer :
The opportunity to work with a top 10 global pharma company
The chance to work on cutting edge medicines right at the forefront of drug development
Genuine career development opportunities for those who want to grow as part of the organization
Flexible conditions and an attractive remuneration package
Responsibilities of the Clinical Research Associate (CRA) :
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.
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.
Bachelor’s degree level (or equivalent) within Medicine, Biological Sciences, Pharmacology, Nursing or relevant life science discipline
At least 1 year of on-site and independent monitoring experience
Work experience within a pharmaceutical company or CRO setting
Good working knowledge of ICH GCP and local regulatory requirements
Ability to independently perform all types of site visit (selection through to close out)
Fluency in English language
Full driving license with the ability to travel to sites across South Africa
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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.