Clinical Research Associate / CRA at inVentiv Health Commercial

Job description

SL-5855

CRA II / Clinical Research Associate II – South Africa

Office based (Johannesburg

Our client, a global pharmaceutical company, is looking for a Clinical Research Associate II to work office-based in Johannesburg (South Africa) when not on-site monitoring. As a CRA II you will manage activities of clinical investigative sites ensuring successful execution of the study protocols. You will be responsible for complex studies with potentially large numbers of sites requiring oversight of operational issues therefore you will have a proven track record as a CRA II.

inVentiv Health: Work Here. Matters Everywhere.

Responsibilities will include:

• Monitors activities conducted by clinical investigative sites
• Plan and conduct investigator and site-staff training
• Conduct site qualification, initiation, interim monitoring and study closeout visits for Phase II-IV studies in accordance with applicable regulations, GCP, ICH Guidelines and SOP as well as business processes.
• Create site specific and monitoring tools
• At the investigational site, ensure clinical drug supplies are available, appropriately used, handled, stored and returned, accurately inventoried and documented.
• Manages and monitors the activities of clinical investigative sites across a number of protocols and multiple therapeutic areas (mainly oncology)
• Conduct site closure visit according to the checklist activities listed on the site closure report
• Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with project team members.

Eligibility/Qualifications/Requirements

• To be eligible for consideration, you will come with:
• Minimum 12 months of clinically related experiences working on a CRA position
• Current in-depth knowledge and understanding of appropriate therapeutic indications (oncology is an asset)
• Experience in on-site monitoring of investigational drug or device trials is required
• Fluent English is required in addition to good Afrikaans (verbal and written).