Clinical Research Associate - Slovensko

PRA international

Place of work
Banská Bystrica region, Banská Bystrica
Contract type
full-time

Information about the position

Job description, responsibilities and duties

Working with our global pharmaceutical client, Clinical Research Associate 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.

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. 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. This will involve establishing innovative ways of increasing site and patient recruitment.

When issues do occur, 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.

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.

Employee perks, benefits

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

PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

Requirements for the employee

Candidates with education suit the position

Secondary with school-leaving examination
Follow-up/Higher Professional Education
University education (Bachelor's degree)
University education (Master's degree)

Language skills

English - Upper intermediate (B2) or
Slovak - Advanced (C1)

Personality requirements and skills

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 Slovak and English language is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.

Experience with the oncology clinical trials is highly desirable.

Advertiser

Brief description of the company

PRA is a top five CRO that has 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.

Company address

PRA international
-
- Prague
Czech Republic
www.prahs.com

Contact

Contact person: HR Dept.
Tel.: 01189181000
E-mail: send CV
Send CV to the company
ID: 2800307   Dátum zverejnenia: 7.11.2016