Clinical Research Associate at Covance

Job description

Covance South Africa is constantly increasing number of Clinical Research Associates working for our Clinical Operation and CoSource (Sponsor based) departments so If you have previous Experience in this field feel free to send us your documents.

CRA positions available to work within our Phase II-IV Clinical Operations Teams or through our CoSource division directly with pharmaceutical companies. As an Experience d CRA you'll be involved in initiation, routine & close out visits concentrating on sites in South Africa. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!

Requirements:

• Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
• Excellent understanding of Serious Adverse Event reporting
• Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in South Africa.
• Fluency in both English

USPs of CRA role:

• Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit' targets
• Join a stable team of CRAs across South Africa and benefit from outstanding training and development, both initially and throughout your career
• Join a company where people tend to stay for 6-10 years rather than 1-3!
• Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance.

Duty Highlights:

• As a CRA you will manage all aspects of study site monitoring according to SOPs, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files. Responsibilities include:
• All aspects of site management as prescribed in the project plans
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
• Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements
• Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
• Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems

Other Information:

These roles are full time & permanent positions employed through Covance.