CRA I or II& SCRAs (m/f)
Home-based or office based (Vienna)
Full-time (1 FTE)
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You'll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.
INC Research / inVentiv Health are currently recruiting for dedicated and motivated CRAs with previous monitoring experience and fluent German to work Home Based or Office Based in Austria. When not site monitoring, you will be working on studies for a global Pharmaceutical client, playing an integral role within an established team.
INC Research/inVentiv Health: Work Here. Matters Everywhere.
This is a great opportunity for someone looking to work on oncologystudies from Phase I-III as a sponsor-based CRA.
As a Clinical Research Associate (Field Monitor) you are the person that serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of clinical studies. A CRA is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site/lab assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out.
* Participates in site/lab assessments, pre-trial site assessment visits and/or study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team
* Acts as primary contact for assigned sites for specific trials and works closely with TM and TA staff regarding study progress and issue resolution.
* Attends/participates in investigator meetings as needed.
* Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
* Ensures site staff have current GCP and necessary protocol and compound training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed internally.
* Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
* Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
* Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
* Ensures site staff complete the data entry and resolve queries within expected timelines.
* Ensures accuracy, validity and completeness of data collected at trial sites.
To apply for this position you must have previously worked as a Clinical Research Associate / CRA in Austria (at least one year of monitoring experience), hold an Austrian passport or valid Austrian work visa, speak fluent German and English and be willing to work home-based or office-based in Austria.
* Degree in scientific or healthcare discipline. Master's degree preferred.
* Experience in monitoring phase II/III studies is preferred.
* A minimum of a few months of clinical trial monitoring experience is preferred, better one or two years or more
* Good knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
* Good IT skills in appropriate software and company systems.
* Willingness to travel with occasional/regular overnight stay away from home depending on the region.
* Proficient in speaking and writing the country language and English. Good written and oral communication skills.
There are many benefits available to employees of INC/inVentiv. They include highly competitive compensation and benefits including: 30 days annual leave, life insurance, accidental death and disability cover and bonuses! The position is offered through a contract of employment with inVentiv Health Clinical.
If you have the required experience for this position and are eligible to work in Germany then please apply or contact Andreas Schulz on +49 (0)30 345 069 11.
If this role is not suitable for your experience but you have worked in clinical research in the industry and would like to discuss other roles, please contact a member of the inVentiv Health Clinical team on +49 (0)30 345 069 11.
To find out more about our company and search and apply for other open jobs please visit our website http://www.inVentivHealthclinical.com