Opening for CRA - Multi-Therapeutic @ PRA Health Sciences - India

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
Fully based at the Hyderabad offices of one of our global pharmaceutical clients, the Central Monitor / Remote Monitor is responsible for conducting remote monitoring, as part of the wider study team. Partnering closely with your Study Manager and Clinical Research Associate colleagues, the Central Monitor remotely reviews and evaluates data from various sources (eCRF, Central Labs etc) to ensure consistency, integrity and completeness.

A key focus of the work of the Central Monitor / Remote Monitor is to proactively seek to identify potential risks or safety issues; implementing corrective actions and escalating these issues when required to ensure timely resolution. Other tasks include performing data query resolution with site staff and / or internal study team colleagues, including Clinical Research Associates and Data Managers as well as interacting with other functional areas including Programming.

Operating as a fundamental part of the pharma client’s clinical trial team, the Central Monitor / Remote Monitor often provides input into the clinical monitoring plan and eCRF design.

Qualifications
The successful candidate for this role will be able to demonstrate prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment. Prior working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential. Fluency in English is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.
Click here to apply

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