职位描述：
Overview
As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.
Responsibilities
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, the Clinical Trial Assistant (CTA) works to support the completion and coordination of various logistical and administrative tasks.
The Clinical Trial Assistant’s (CTA) work is 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 with 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) also falls within the CTA’s remit.
Functioning as a key component of the clinical study team, the Clinical Trials Assistant (CTA) may also be responsible for scheduling meetings, updating Excel trackers, coordinating the translation of site documents and providing ad-hoc support as appropriate.
Requirements
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 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.
