Clinical Research Associate
- Employer
- ICON Strategic Solutions
- Location
- Poland
- Salary
- Competitive
- Start date
- 25 Jun 2022
- Closing date
- 30 Jun 2022
View more
- Discipline
- Clinical Research, Clinical Trials Manager / Administrator
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
As a Clinical Research Associate (CRA) you will be dedicated to one of our global Healthcare clients who have a strong legacy of innovation and leading the way within a specialist therapeutic area. They display an ongoing commitment to changing the lives of patients and the accessibility of products in order to change the lives of those that need them. The CRA is the primary point of contact between site staff and sponsor. This CRA will be responsible for taking leadership of site management for the selection and initiation of sites on behalf of the sponsor, as well as conducting and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, sponsor´s procedures and protocol requirements. Responsibilities
- Perform all type of visits from site feasibility to close out visits according to plan, document actions and follow up on action plans
- Train and guide site staff in safety information handling, systems, protocol and trial procedures to minimize protocol deviations
- Proactive use of EDC and other data source systems for preparation and conduct on site visits as well as source data verification in collaboration with data management/logistics team
- Identify potential risks and proactively take action to prevent or mitigate
- Collaborate with Data Management/logistics in resolving queries
- Assist to ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
- Motivate and build strong relations with site personnel to assist the sponsor in being their preferred clinical research partner
- Collaborate with and provide oversight of deliverables from vendors locally, if applicable
- Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
- Participate in Investigators Meetings to ensure relations with sites as well as active presentation as applicable
- Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
- Support audits and inspections at sites and affiliate, as applicable
Qualifications
- Bachelor or Master’s degree in life sciences or other relevant fields.
- 1-3 years of experience as a Clinical Research Associate.
- Therapeutic area knowledge and demonstrating an understanding of diabetes, psychiatric, neurology, cardiology studies or similar is an advantage.
- Excellent knowledge of Clinical Trial Management Systems, Good Clinical Practices and Trial Management.
- Strong analytical and communication skills with business, industry understanding and stakeholder management.
- Fluent in both Polish and English.
- Valid driver’s license
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.
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