CRA II / Clinical Research Associate II / Poland
Home based (Warsaw area)
Our client- global pharmaceutical company, is looking for a Clinical Research Associate II to work home based in Poland (Warsaw). 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 I-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 (e g , temperature logs, security), and returned, accurately inventoried and documented.
* Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas
* 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.
To be eligible for consideration, you will come with:
* Minimum 6 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 Polish is required in addition to good English (verbal and written).
If you have the required experience for this position and are eligible to work in Poland then please apply to: Katarzyna Chromiak at
To find out more about our company and search and apply for other open jobs please visit our website http://www.inVentivHealthclinical.com
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance.