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08.06.2020, Ref.#: CRA I and II
Clinical Research Associate (CRA I and II), КОМАК МЕДИКАЛ ЕООД  Вижте визитка на компанията
Месторабота София; Постоянна работа; Пълно работно време
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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)

The Profile:
- Conducts feasibility studies, as requested
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Gains an in-depth understanding of the study protocol and related procedures
- Conducts site qualification visits
- Collects, reviews, and monitors required regulatory documentation for study start-up, study mainte-nance and study close-out
- Customizes patient information sheets and consent forms, as required
- Participate, if requested, in the preparation of and review of study documentation e.g. draft protocols, draft CRFs;
- Participates in contracting process, if required
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, re-tention, protocol deviations, regulatory documentation, site audits/inspections and overall site perfor-mance.
- Performs remote and on-site monitoring & oversight activities
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CTL/CMM/PL
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines
- Assists in audit preparations;
- Updates and maintains tracking logs, if required
- Performs project-specific documents translations, if required;
- Assists in the planning and execution of Investigator Meetings or other study related meetings;
- Assume additional responsibilities as directed by Project Manager.



The Person:
- Graduate or postgraduate degree
- At least 1 years as a Clinical Research Associate/Clinical Monitor
- Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.
- Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations.
- Excellent organizational, communication (verbal and written) and interpersonal skills.
- 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.



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.


The Assigned Country: Bulgaria

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.


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