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 12 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 Project Administrator / Regulatory Specialist based in Tbilisi, Georgia

Job summary:

As a Clinical Project Administrator/ Regulatory Specialist you will be expected to provide clerical support to project team during the study conduct, assist in regulatory submission and Clinical Research Associate activities at the study start and perform other administrative duties as assigned by management. We are searching for a positive and energetic person, eager to learn, push forward administative processing of the documents and function well in the project team. The suitable candidate shall have desire to develop in Regulatory activities and specialise with the time in Regulatory submissions and requirements for Georgia.

Main Tasks of the Position:

  • Provides clerical support to project team (e.g., word processing, proofreading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.)
  • Sets up and maintains clinical investigator files and trial and master files
  • Prepares investigator budget payments and tracking systems; generating tracking reports as assigned
  • Performs data entry and maintenance of selected study tracking databases
  • Prepares monitoring visit documentation for Clinical Research Associate
  • Prepares study-related documents and other materials for delivery to archives, at appropriate intervals
  • Assists in submission and other Clinical Research Associate activities e.g. compiling of regulatory packages, translation of clinical documents, updating trackers, assisting in feasibility
  • Participates in all activities that lead to start up of investigational sites
  • Takes part in the communication with Regulatory Authorities and Ethics Committees
  • Interacts with Customers when receiving requirements from Regulatory Authorities
  • Assists in project management activities such as organizing meetings, taking minutes, following up on outstanding issues with the study team members; financial data collection and tracking

Required Qualifications, Experience, Competencies:

  • Excellent written and oral communication skills in English and Georgian
  • Excellent organizational and time management skills
  • Attention to detail
  • Ability to work well within a team
  • Flexibility, ajustability, initiative
  • Open to learn new things and communicate across countries and cultures
  • Independence in work
  • Computer competency
  • Previous experience in clinical research field is an advantage
  • Background of natural science is an advantage
  • Position is highly suitable for Study Coordinators

Benefits:

  • Working with experienced and very professional and supportive team
  • Possibility to grow within the Company
  • Competitive remuneration
  • Eligibility to the Company Bonus scheme

Apply for job


Max. file size: 2M