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.
For more information please see our website:
Working in PRA Health Sciences team office based in Kiev or home based anywhere in Ukraine, the Clinical Research Associate/ Senior Clinical Research Associate (CRA/SCRA) is ultimately responsible for the successful management of investigator sites throughout the site life-cycle, whilst working in accordance with ICH-GCP guidelines, the study protocol, applicable local and international regulatory requirements and internal Standard Operating Procedures.
With full ownership of investigator sites for assigned studies, the CRA's/SCRA's involvement begins at site feasibility stage, with responsibility for the successful management of the site right through to close-out.
PRA is currently looking for specialist who would overtake the following duties:
Implementation and monitoring of clinical trials according to local regulatory requirements and ICH-GCP guidelines Review and verification of clinical trial data collected Source document verification and query resolution Communication with investigative sites Facilitate audits and audit resolution Mentoring of junior level CRAs Leading of observation and performance visits Senior employee - Leading of assigned projects and within the Clinical Operations department
Desired skills and qualifications:
We are currently seeking for the person who possess such a skills:
Knowledge of ICH and local regulatory authority regulations regarding drug Prior clinical trial monitoring experience Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required Fluent Ukrainian and English
Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.
If you have any questions please email or call our recruitment department at (0) .
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.