Senior Clinical Research Associate
- Employer
- ICON Strategic Solutions
- Location
- Poland
- Salary
- Competitive
- Start date
- 29 Jun 2022
- Closing date
- 21 Jul 2022
View more
- Discipline
- Clinical Research, Clinical Trials Manager / Administrator
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
As a Senior CRA, you will be dedicated to one of our global Biotechnology clients who pride themselves on their quality and patient centric approach. They continue to challenge the status quo whilst ensuring the highest standards of compliance and acknowledging the importance of both global and local expertise
Responsibilities
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.
- Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.
- Provides regular site status information to team members, trial management, and updates trial management tools.
- Completes monitoring activity documents as required by SOPs or other contractual obligations.
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
- Escalates site and trial related issues per SOPs until identified issues are resolved or closed.
- Performs essential document site file reconciliation.
- Performs source document verification and query resolution.
- Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.
- Verifies SAE reporting according to trial specifications and ICH GCP guidelines.
- Communicates with investigative sites.
- Updates applicable tracking systems
- Functions independently with minimal oversight required
- May serve as subject matter expert for clinical operations on monitoring-related activities
Qualifications
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed healthcare professional (ie, registered nurse); or equivalent work experience required.
- Read, write, and speak fluent English; fluent in host country language required.
- 4-5 years clinical monitoring experience required.
- Oncology experience preferred.
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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