COMAC MEDICAL is a Full Service CRO/ SMO providing a broad network of clinical research sites in the best healthcare institutions across Central and Eastern Europe. Due to our successful development we are looking for our new projects in Romania for highly motivated and responsible candidates for the position of:
SITE COORDINATOR II
Knowledge, skills & abilities:
- Graduate or postgraduate degree
- At least 1 year’ experience in the field of clinical research
- Working knowledge of current ICH/GCP guidelines, applicable regulations (including country specific ones), and current industry practices.
- Excellent organizational, communication (verbal and written) and interpersonal skills.
- Proficiency in English.
- Positive attitude and ability to interact with all levels of staff.
- Ability to work under pressure and to keep tight deadlines.
- Working knowledge of Word, Excel, and Power Point.
- Conduct all types of feasibility inquiries at the respective site(s);
- Support the site team with regards to subject pre-selection and recruitment;
- Support the site team in subjects’ visits planning and preparation
- Prepare and organize source documentation;
- Complete Case Report Form;
- Collaborate and facilitate monitor on-site or remote visit;
- Maintain Investigator Site File;
- Participate in and if required coordinate any trainings and meetings (incl. Investigator Meetings) related to a specific study;
- Collaborate with the site team for any adverse events and safety information reporting and escalation;
- Organize and coordinate study medication and other study supplies (including biological samples) import/ export, logistics, etc.
- Ensure timely site equipment maintenance and calibration
- Handle subject expenses reimbursement;
- Perform additional study specific procedures, as delegated by the PI
The Assigned Country: Romania.
If you are interested in such an opportunity please send your CV and a cover letter in English describing why your experience and skills make you a good candidate for this position.
Only short listed candidates with enclosed cover letter will be contacted for interviews