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Full-Time Clinical Research Associate Budapest – CRA/SCRA

HungaryCRO – Posted by HungaryCRO Budapest, Budapest, Hungary

Job Description

Clinical Research Associate / sCRA

Budapest / Hungary

We are CEE CRO looking for an experienced Clinical Research Associate who will be involved in feasibility studies, setting up, monitoring and on-site quality control of multi-centre international clinical trials in novel pharmaceuticals. The position is a full-time one, and we welcome applications from candidates who can work in our new office in Budapest.

Requirements

MD, PharmD, or university degree in life sciences or relevant experience
At least 1 year of independent monitoring experience(experience in routine monitoring, selection, initiation and close-out visits)
Experience in regulatory submissions, contract negotiations, site management and feasibility assessment
Valid driver’s license and ability to travel
Proficient user of standard MS Office applications
Fluency both in English and Hungarian

Job description

FIELD WORK (Preparation, conduct, and reporting of selection, initiation/start-up, routine/interim and close-out monitoring visits, Site management)
COMMUNICATION AND TRAINING (Communication point for investigational sites, Back-up communication line for vendors and support services, Onsite training of investigators and staff, Preparation and delivery of presentations at investigators’ meetings)
QUALITY CONTROL AND ASSURANCE (Supervised quality control of miscellaneous outbound documents, Preparation for and attendance at company’s audits)
DOCUMENT MANAGEMENT (Liaison with sites on miscellaneous study documentation matters, Preparation and distribution of Onsite Study Files to the sites)
REGULATORY AFFAIRS (Providing support to the Regulatory Affairs staff in procurement of site regulatory documents)
DATA MANAGEMENT (Participation in query resolution, Maintenance of study-specific automated tracking systems)
FEASIBILITY (Participation in feasibility research).

We offer

Excellent working conditions and extensive training combined with good opportunities for personal and professional growth (email: hungarycro@gmail.com).

Job Categories: Pharmaceutical. Job Types: Full-Time.

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