EastHORN Clinical Services in CEE Ltd is a clinical contract research organisation (CRO) serving global pharmaceutical and biotechnology companies in the development of new medicines. The company has operations throughout Central and Eastern Europe. Since starting 10 years ago, we have grown and have established operations in more than 15 countries.

Our international clients value our enthusiastic and flexible approach to meeting their needs and we are growing rapidly. To support our further growth, we are looking for a

Clinical Research Associate, based in Bucharest, Romania

Job summary:

As an experienced Clinical Research Associate you will be expected to actively participate in and manage the recruitment of potential investigators. 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 the Clinical Operations Manager, you will be a key member of the Clinical Operations team in Romania.

We are searching for an experienced, ambitious and energetic person, able to undertake challenges in the project, push forward development of the project 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 include, but are not limited to:

• Performs investigator identification and site selection and conducts pre-study visits for qualification of investigators and sites

• Prepares and facilitates site training and initiation

• Verifies clinical data against source document during routine monitoring and assist efficiently in query management process and IP accountability and reconciliation.

• Completes monitoring trip reports, reporting study progress, escalating issues related to the protocol, and ensuring patient safety and ICH/GCP compliance within EastHORN and/or Sponsor timelines and quality

• Ensures all site queries are resolved and recorded in a timely manner

• Organizes translation and provides final approval of study documents, as required

• Manages adverse event reporting and follow up

• Prepares and negotiates study budgets and contracts for the site, investigator, and study vendors and assists in obtaining contract signatures

• Prepares, organizes, and oversees site, investigator, and vendor payments

• Provide feedback and support during appraisal process, performing co-monitoring visits Depending on experience, become involved (at request) in other study management areas and staff training

• Review and development (at request) of study essential documents

• Act in Lead role on a project, assuming additional responsibilities as retailed by Line Management  Assisting in business development when appropriate

Competencies

• Minimum 2 years of independent monitoring experience

• Life sciences background is required

• University Degree in Medicine is an advantage

• Experience in Oncology is an advantage

• Excellent knowledge of the clinical trial process and ICH/GCP guidelines

• Experience with Electronic Data Capture is required

• Excellent organizational and time management skills to handle multiple priorities

• Leadership skills

• Ability to work and to take proper decisions under presure

• Flexibility to travel

• Cost effective abilities

• Excellent written and oral communication skills in Romanian and English

• Social and soft skills

Benefits:

• Working in experienced and very professional team

• Possibility to grow within the company

• Flexible approach to work time

• Car allowance

• Competative remuneration

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

 

Apply for job