Clinical Research Associate (CRA，临床监察员) One of the world’s largest CROs, PRA HealthSciences is transforming clinical trials through our people, innovation and operational transparency. Our 10,000+ employees operate in more than 80 countries, delivering a broad spectrum of clinical trial solutions that meet the demands of a diverse marketplace.
It is our philosophy that the way in which we grow our business is to focus on our employees. As such, we recognize that successful careers are found within organizations that provide the support that employees need at work, the benefits they require outside the office as well as a good work / life balance.
1. With full ownership of investigator sites for your assigned studies, your involvement begins at site feasibility stage, with responsibility for the successful management of the site right through to close-out.
2. In addition to planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan, you will foster effective relationships with investigator site staff to ensure that key clinical metrics are met.
3. This will involve establishing innovative ways of increasing site and patient recruitment. When issues do occur, the Clinical Research Associate proactively and promptly implements corrective action plans, and, when applicable, escalates issues to more senior members of the study team. You may also design and deliver training to site staff, when appropriate.
4. Typical duties will likely include preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues that have occurred at your site. You will ensure the integrity of clinical data through your ability to sufficiently maintain site tracking records and work diligently to relevant guidelines.
5. Through your ability to operate as a key part of a global study team, you will play a fundamental role in our client’s drug development process.
1. Tertiary qualification; life science, medical, paramedical, pharmaceutical related degree
2. Minimum 1 year monitoring experience. Preference is given to candidates with at least 2 years of global trial experience, working for global pharmaceutical company or global CRO
3. Demonstrated strong understanding of company’s systems and processes
4. Demonstrated proficiency in the monitoring and management of clinical trials
5. Team orientated personality with high degree of flexibility
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.