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Clinical Research Associate (CRA) *** Hungary*** Home based

Employer
ICON Strategic Solutions
Location
Hungary
Salary
Competitive
Start date
23 May 2022
Closing date
7 Jun 2022

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Job Details

Description:
* Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
•* Acts as primary local company contact for assigned sites for specific trials.
•* Attends/participates in investigator meetings as needed.
•* Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
•* Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
•* Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
* Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
•* Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
•* Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).

Profile:

•* A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
Only Hungarian citizen
•* Must have experience in Clinical Research or equivalent qualification
•* 1-2 years' experience monitoring on site
•* Specific therapeutic area experience may be required depending on the position.
•* Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
•* Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
•* Proficient in speaking and writing the country language and English.
•* Good written and oral communication skills.
#jobcra

Company

As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.

ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.

Why choose a career with ICON Strategic Solutions?

Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.

Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.

Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.

Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.

Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.

Company info
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