Ref #: 32488

Employment type: Permanent - Full-Time

Location: South Africa

Posted: 14-Oct-2021

Description

In this role, you are the primary contact point between the sponsor and the investigational site, assigned to trial sites ensuring inspection readiness through compliance with regulatory guidelines and company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP) from start-up through data-base lock.

Your main responsibilities include;

- Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial.
- Main point of contact for sites to ensure successful collaboration, meeting Sponsor expectation on milestone and deliveries
- Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects.
- Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate
- Conducts continuous monitoring activities (onsite and remote).
- Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety. Is accountable for continuously updating all electronic systems (global and local) relevant to perform job functions.
- Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.).
- Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements.

If you are seeking the next step in your career, with a competitive salary and benefits package, together with long term development opportunities, please send your CV for review to alison.burton@docsglobal.com as soon as possible

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