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Cluj-Napoca, Brașov, Constanța, Ploiești, Oradea, Craiova, Galați, Timișoara
Clinical Trials Assistant (CTA) - Romania
Working fully outsourced at one of our global pharmaceutical clients, the Clinical Trial Assistant plays a fundamental role in the successful execution of global clinical trials. Operating within the scope of the Clinical Development Plan, ICH-GCP guidelines and in accordance with the study protocol, local and international regulatory requirements and company procedures, you will work to support the completion and coordination of various logistical and administrative tasks.
Your work will be varied, fast-paced and quality focused. Typical duties will include supporting other members of the local study team, including Clinical Research Associates and Lead Monitors, collecting data required for regulatory submissions, document tracking (contracts, financial agreements, patient informed consent forms, insurance certificates) and managing the delivery of non-drug related study supplies. Maintaining constructive relationships with site staff (eg Investigators, Study Coordinators etc) as well as your colleagues within the organisation, the Clinical Trial Assistant is responsible for tracking site budget related matters, including processing invoices, tracking payments etc. The maintenance and updating of the Trial Master File (and preparation for relevant QC checks when applicable) will also fall within your remit.
Functioning as a key component of the clinical study team, you may also be responsible for scheduling meetings, updating Excel trackers, coordinating the translation of site documents and providing ad-hoc support as appropriate.
To be considered for this position, you must be have a degree (or equivalent) in a relevant life-sciences discipline (nursing, biology etc) along with previous experience in a similar role, either in a pharmaceutical company or a CRO.
Fluency in English and Romanian is essential, along with proficiency in the use of Microsoft Office suite. Demonstrable experience of working to high quality standards and resolving issues will also feature in your profile.
The ability to effectively communicate with others and foster positive working relationships will guarantee success within this role.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.