As a Clinical Research Associate you will be expected to actively participate in and manage the recruitment of potential investigators and perform other CRA activities in Romania and Republic of Moldova.
We are searching for an experienced professional in clinical research who is willing to cover projects in Moldova as well. The desired person shall be open to deal with Regulatory Submissions, contracts negotiations and other activities in the project.
We are looking for the following:
- Relevant CRA experience for at least 3 years
- Medical/Pharmaceutical university degree constitutes an advantage
- Excellent knowledge of the clinical trial process and ICH/GCP and local requirements/ guidelines
- Excellent organizational and time management skills
- Friendly and warm personality
- Competent in handling difficult situations
- Able to communicate effectively
- Able to remain calm and efficient under pressure
- Supportive of colleagues
- Charisma, natural radiance, and a well-groomed appearance
- Excellent knowledge of English and Romanian (writing and speaking)
- Excellent written and oral communication skills
- Strong multitasking abilities
- Exceptional attention to detail
- Proficiency in PC-based applications (Microsoft Office applications)
- Availability for domestic and international travels
- Excellent planning and organizational skills
- Ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately.
- Ability to work independently.
Responsibilities and job description
- Locating and assessing the suitability of facilities at the study site;
- Briefing doctors/consultants (or investigators) on conducting the trial;
- Setting up the study sites;
- Monitoring the clinical trial throughout its duration, which will involve visiting the study sites on a regular basis in accordance to monitoring plan;
- Verifying that data entered on to the CRFs is consistent with patient clinical charts (SDV);
- Writing monitoring reports in a timely fashion;
- Filing and collating trial documentation and reports;
- Ensuring all unused trial supplies are accounted for;
- Closing study sites on completion of the trial;
- Archiving study documentation and correspondence.
-Working with experienced and very professional and supportive team
-Possibility to grow within the Company
Clinical Trial Center is an independent full-service company in the area of clinical research with national coverage and providing phase II - IV clinical trial related services to pharmaceutical companies.
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