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24.06.2020
★★★★★ Clinical Research Associate, ИйстХОРН КЛИНИКАЛ СЕРВИСЕС ИН СИИ ЕООД
Месторабота София; Постоянна работа; Пълно работно време; Езици: Английски
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Clinical Research Associate

EastHORN Clinical Services is a clinical research organisations (CRO) in Europe. We operate in over 15 countries in the region with an experienced staff comprised largely of physicians and PhDs. We serve global pharmaceutical and biotechnology companies in the development of new medicines and modern medical technologies. The company has operations throughout Europe and since starting 16 years ago, we have expanded significantly.

Our international clients value our enthusiastic, flexible and quality-focused professional approach to meeting their needs, and we are continuing to grow further. To support our future development, we are currently looking for a


Clinical Research Associate,
based in Sofia, Bulgaria



Job summary:
As an experienced Clinical Research Associate you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors and other duties. You will function as the primary contact for sites regarding regulatory compliance and protocol questions and communicate with clinical sites on an ongoing basis to address and resolve issues. Reporting to Senior Clinical Operations Manager, you will be a key member of the Clinical Operations team in Bulgaria.

We are searching for an experienced, ambitious and energetic person, able to undertake challenges in the project, push forward development of the study and function well in the project team. The desired person shall be open to cross cultures communication and cooperation and shall be significantly independent in their performance.

Main Tasks of the Position:
  • Responsible for recruitment of potential investigators, involvement in CA and EC submissions and notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
  • Responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study initiation visits, regular visits and close out visits, assists on audit/inspection visits and assists in site and vendor contracting process, liaison with vendors and other duties
  • Functions as the primary contact for sites regarding regulatory compliance and protocol questions and communicates with clinical sites on an ongoing basis to address and resolve issues
  • Assists in Business Development activities
  • May have supervisory functions in clinical projects
  • May be required to train, coach and supervise junior staff
Required Qualifications, Experience, Competencies
  • Excellent knowledge of the clinical trial process and ICH/GCP and local requirements/ guidelines
  • Excellent organizational and time management skills
  • Skills to handle multiple priorities and to work with deadlines and under pressure
  • Excellent written and oral communication skills
  • Skills to coach and mentor other clinical staff
  • Fluent in written and verbal English and Bulgarian
  • Computer skill
Benefits:
  • Working with experienced and very professional and supportive team
  • Possibility to grow within the Company
  • Competitive remuneration
  • Flexible working time
  • Eligibility to the Company Bonus scheme
  • Additional private healh insurance
  • Car allowance 
If you are a reliable and positive individual who would like to be part of, and to contribute to the further success of an expanding young Company within a meaningful and growing market, please send your CV and cover letter in English by pressing the button Apply
I hereby agree to the processing of personal data included in my job application, for the purposes of the recruitment process, according to the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, unified text published in the Official Journal of the European Union of 4 May 2016
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