RESEARCH ASSISTANT

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:

RESEARCH ASSISTANT I

Knowledge, skills & abilities:

- Graduate or postgraduate degree

- 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.

Responsibilities:

Project Duties/Responsibilities:

- Assist in the investigator site selection and qualification, as directed;

- Updates and maintains tracking logs, as required

- Collects and file initial and ongoing study documentation for submission/notification to Competent Authority;

- Assists CRA with developing/printing Trial Master File as well as Investigator Site Files binders

- Assists LCRA/CRA with mailings to sites, faxes, regulatory documents

- 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/LCRA

- Performs project-specific documents translations, if required;

- Assists, as directed, in file audits

General responsibilities:

- Represent Comac Medical in a professional manner.

- Perform other duties as assigned by Leadership.

- Follow strictly the applicable for the position company policies and procedures.

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.