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. 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.
The In House Clinical Research Associate (IHCRA) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. At the Senior level, the IHCRA will manage and lead all activities listed above and will ensure that all activities meet Sponsor and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.
Supporting our Core Team at our PRA office, the IHCRA 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 IHCRA works to support the completion and coordination of various logistical and administrative tasks.
The IHCRA work is varied, fast-paced and quality focused. Typical duties will include supporting other members of the local study team, including Clinical Research Associates (CRA) 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 IHCRA 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 IHCRA ’s remit.
Functioning as a key component of the clinical study team, the IHCRA may also be responsible for scheduling meetings, updating Excel trackers, coordinating the translation of site documents and providing ad-hoc support as appropriate.
In addition to the above:
To be considered for this position, you should have a bachelor degree (any discipline). In the case of having diploma as the highest education attained, you should have a few years of relevant industry experience.
Ideally we would like minimum 1 year experience as CTA supporting clinical study projects. However, we would welcome candidates with other relevant industry experience to apply with us.
Ability to read, write and speak basic English is essential, along with proficiency in the use of Microsoft Office suite. Document translation between English and Chinese is sometimes required.
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.
This position is based in Beijing or Shanghai.