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.
PRA Health Sciences Shanghai China is currently looking to hire experienced Clinical Research Associate (CRA) to join our business and fully integrated into one of our (exclusive) strategic global partners, via our Strategic Solutions Division. Our aim in Strategic Solutions Division is to deliver the customized services to our global partners with our customized solutions designed to manage large and mid-size biopharmaceutical companies’ pipeline portfolios more efficiently and with greater flexibility and control. Reporting into a Clinical Operations Manager, you will be responsible for clinical trial activities from site initiation to routine monitoring and close-out of clinical trials. A proven Clinical Research Associate (CRA) with minimum 2 years of independent multi-site monitoring experience is expected.
Working fully outsourced to and based at the offices of our global pharmaceutical client, the Clinical Research Associate (CRA) is ultimately responsible for the successful management of investigator sites throughout the site lifecycle, whilst working in accordance with ICH-GCP guidelines, the study protocol, applicable local and international regulatory requirements and internal Standard Operating Procedures.
Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.
As a Clinical Research Associate, you will be dedicated to one of our global pharmaceutical client; with whom PRA shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market. Leading by example, you can set the standard of excellence and enjoy a challenging career in this exclusive program.
The Clinical Research Associate is ultimately responsible for the successful management of investigator sites and monitoring activities for assigned clinical studies throughout the trial lifecycle. Key responsibilities include:
* Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
* Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
* Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines.
Passionate, innovative and committed.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
* Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
* A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
* You will be educated to degree level in a life science discipline or be a licensed healthcare professional.
* Experience working on Oncology trials or complex studies would be an advantage for this role.
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
For more information please visit our website: www.prahs.com