EastHORN Clinical Services is a clinical research organisations (CRO) in Europe. We operate in over 20 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 18 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, Romania

Job summary

As a Clinical Research Associate you will be expected to actively participate in and manage the recruitment of potential investigators, perform other CRA activities in Romania. Reporting to Senior Clinical Operations Manager, you will be one of the key members of the Clinical Operations team Romania.

We are searching for an experienced professional in clinical research with experience in local submissions who is willing to cover projects in Romania. The desired person shall be open to deal with Regulatory Submissions, contracts negotiations and other activities in the project.

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
• Provides interpretative assistance of guidance documents and regulatory rules and ensures their communication through company policies and procedures
• Provides training and support to CRAs in order to collect all necessary documents for start up package and IP release

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
• Fluent in written and verbal English and Romanian
• Computer skill

Benefits

• Working with experienced and very professional and supportive team
• Possibility to grow within the Company
• Competitive remuneration
• Flexible working time
• Additional Medical insurance
• Eligibility to the Company Bonus scheme

If you are a reliable and positive personality and would like to contribute to the further success of a dynamic young company in a growing market, please send your CV and motivation letter in English to: careers@easthorn.eu or complete the form below: