CRAII/ Senior CRA / Poland Full-time
inVentiv Health: Work Here. Matters Everywhere.
Our client- global pharmaceutical company, is looking for a Clinical Research Associate II or Senior Clinical Research Associate (SCRA) to work home based in Poland. As a SCRA 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 CRAII or Senior CRA.
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-III 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 mainly in oncology area.
* 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:
* Prior monitoring experience
* Current in-depth knowledge and understanding of appropriate therapeutic indications
* Experience in oncology therapeutic area nice to have;
* Experience in on-site monitoring of investigational drug 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:
To find out more about our company and search and apply for other open jobs please visit our website http://www.inVentivHealthclinical.com