Great job opportunity for a RESARCH ASSISTANT I for one of the most reputable, full-service providers of CRO, COMAC MEDICAL, with headquarter in Sofia, Bulgaria. 
Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, we are a recognized leader in clinical research and provide innovative and non-conventional solutions of high quality for the pharmaceutical industry. 
We are looking for a proven professional to join our team in Georgia. 
 
What is expected to be done: 

• Assist in the investigator site selection and qualification, as directed; 
• Updates and maintains tracking logs, as required 
• Maintains project-specific company folders 
• Collects and file initial and ongoing study documentation for submission/notification to Competent Authority; 
• Assists CRA with ITMF (ISF) preparation 
• Assists CTL/CRA with site correspondence 
• Scans and uploads documents to the eTMF system if applicable, ensure documents are of good quality before upload 
• Prepares and sends documents for paper TMF 
• Assists in the planning and execution of Investigator Meetings 
• Assists in the planning and execution of monitoring activities as requested by CRA/CTL 
• Performs project-specific document translations, if required; 
• Assists, as directed, in file audits 

 
What is required for the role? 

• Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry 
• Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations 
• Positive attitude and ability to interact with all levels of staff 
• Proficiency in English 
• Ability to work under pressure and to keep tight deadlines 
• Working knowledge of Word, Excel, and PowerPoint. 

 
Why to join Comac Medical? 

• Great team of knowledgeable, high-achieving and experienced professionals; 
• International and diverse work atmosphere; 
• Challenging projects in a different therapeutic area as well as in early phases; 
• Opportunity to enrich professional skills and progress in career development; 
• Competitive remuneration; 
• Professional trainings; 

 
Core strengths of Comac Medical 

• Proven track record for quality and delivery; 
• Established and trusted relationships with KOLs; 
• Motivated, capable and dedicated team; 
• Global full-service capabilities; 

 
If you are interested, challenged, and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English. 
Only the shortlisted candidates will be contacted in a timely manner.