Clinical Research Associate
- Employer
- ICON Strategic Solutions
- Location
- Poland, Homeworking
- Salary
- Competitive
- Start date
- 22 Mar 2023
- Closing date
- 30 Mar 2023
View more
- Discipline
- Clinical Research, Clinical Operations
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
As Clinical Research Associate, you will be dedicated to one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. You will work on a range of therapeutic areas including Cardiovascular, Immunology, Neuroscience, Solid Tumors and Hematology. Working in this way, you will have the opportunity to build your career in a rewarding customer-focused environment that supports creativity, collaboration and performance.
Responsibilities:
- Managing assigned study sites and networks, conducting phase I-IV protocols according to the monitoring plan and sponsor's procedures;
- Being the frontline liaison between the sponsor and sites to ensure successful collaboration, meeting sponsors expectation on milestone and deliveries;
- Performing remote and on-site monitoring activities to ensure compliance with protocol, ICH-GCP, global and local regulations, global and local processes to secure data integrity and patient safety;
- Conducting continuous monitoring activities (on-site and remote) to ensure that study milestones for sites responsible are met as planned; (i.e., study start-up, recruitment, database analyses, closeout, etc.)
- Conducting site visits including but not limited to selection visits, initiation visits, monitoring visits, close-out visits per SOPs and applicable regulations and documenting monitoring activities appropriately following sponsor's standards;
- Identifying issues at sites; resolving issues and escalating as appropriate;
- Managing and maintaining information and documentation by updating all electronic systems (global and local) relevant to perform job functions;
- Participating from audit organization and inspection readiness activities for monitoring and site related activities as required and ensuring implementation of corrective actions within specified timelines
Requirements
- BA/BS , preferably in the Life Sciences, or RN
- Previous monitoring experience (minimum 12 months) is essential gained in pharma/CRO.
- Ability to travel domestically (a minimum of 50% overnight travel may be required).
- Ability to anticipate potential issues and take appropriate actions with or without supervision.
- Good knowledge of concepts of clinical research and drug development
- Strong working knowledge of EDC, IVRS and CTMS systems
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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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