Clinical Research Associate (CRA I and II)

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 Bulgaria for highly motivated and responsible candidates for the position of:

Clinical Research Associate (CRA I and II)
Location: Sofia

The Profile:
− Site (medical center) selection and qualification (in cooperation with the responsible CTM);
− Study set-up with regard to submission/ approval process and preparation of the documentation according to study protocol, company SOPs, applicable regulations and Good Clinical Practice;
− Monitoring and quality control over the investigational sites;
− Planning and performing of monitoring visits in accordance with GCP and the study protocol;
− Reporting trial progress to the sponsor - writing reports and collecting trial specific data, keeping correspondence, attending investigational meetings and project teleconferences;
− Provide prompt personal reporting to Senior management;
− Performing feasibility tasks;
− Contract negotiations and payment management;
− Submissions to Regulatory Authority and Ethics Committee/s;
− Initial and ongoing training of Site staff.

The Person:
− University degree in Medicine, Pharmacy, Chemistry and Biology is preferable;
− Experience in clinical research as CRA;
− Good knowledge of spoken and written English;
− Very good attention to details, excellent analytical capabilities;
− Responsible, pro-active, well-organized and committed person, team player;
− Ability to work under pressure and to keep tight deadlines;
− Willingness to expand his/her professional expertise;
− Valid driver’s license;
− Availability for regular travel.

The Company Offer:
− Job-specific training;
− Work for a successful international company, excellent career development opportunity in a perspective professional field;
− Competitive and result orientated remuneration;
− Additional benefits related to work performance.

If you are interested in such an opportunity send your CV and a cover letter in English to: hr@comac-medical.com, describing why your experience and skills make you a good candidate for this position.