Great job opportunity for a RESARCH ASSOISTANT for one of the most reputable, full-service providers of CRO and SMO, COMAC MEDICAL, with headquarter in Sofia, Bulgaria.
Established in, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, we are a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.
Currently we are looking for a proven professional to join our team.
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 prior to 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 documents 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 Power Point.
Why to join Comac Medical?
- Great team of knowledgeable, high-achieving and experienced professionals;
- International and diverse work atmosphere;
- Challenging projects in a different therapeutical 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.