Clinical Research Associate
hace 4 semanas
This role is with ICON plc, an inclusive employer and a member of the LGBTQ+ business community.
As a Clinical Research Associate (CRA), you will coordinate all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations, and standard operating procedures.
In this position, you will be a decision maker, solving problems independently or as part of the client and ICON team.
You will be managing competing priorities, supporting the on-site team, ensuring investigators follow the clinical trial protocol, providing training, and motivating the team to ensure high-quality results.
Key Responsibilities:
- Monitor multiple Phase I, II, III & IV clinical trial sites across different therapeutic areas.
- Assist other CRAs with co-monitoring activities both remote and on-site.
- Utilize a customer service mindset with sites to deliver value, build loyalty, and trust to create a positive impact and strong relationship with investigators and study coordinators.
- Collaborate with the team to develop commitment to study timelines and objectives through regular visits with site staff in-person and remotely.
- Review "source to CRF/eCRF" to ensure patient safety and data integrity aspects of the study.
- Evaluate sites' adherence to GCP/ICH practices to ensure quality of study conduct.
Requirements:
- Bachelor's Degree (or equivalent) with 2-4 years of relevant healthcare experience in the pharma or clinical research industry.
- Minimum 3 years of monitoring and site management experience.
- Strong experience in phase 1 trials.
- Scientific background.
- Proficiency with medical terminology.
- Working knowledge of Local Regulations.
- A demonstrated working knowledge of ICH/GCP Guidelines.
- Excellent record-keeping skills and attention to detail.
- Experience conducting Site Selection, Initiation, Routine Monitoring, and Close Out Visits both remotely and on-site.
- Fluent in English, both written and oral.
- Strong technical skills with CTMS, eCRF, eTMF.
Why 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.
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