job description - Clinical Research Associate
- You will monitor multiple Phase clinical trial sites, across different therapeutic areas.
- You will utilize your customer service mindset with your sites focusing on delivering value, building loyalty and trust to create a positive impact and strong relationship with investigators and study coordinators where respect, knowledge and commitment to ICH/GCP guidelines are key to successful trial conduct.
- You will collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely.
- You will be first to review "source to CRF/eCRF," ensuring patient safety and data integrity aspect of the study.
- As the first point of contact for study sites, escalating any concerns/issues to other departments including Safety, Investigational Medicinal Product, Local Study Managers and management team as appropriate.
- Additionally, you will oversee the sites' adherence to GCP/ICH practices, ensuring quality of study conduct.
- A minimum of 12 months of independent on-site monitoring experience
- Relevant Bachelor’s Degree (or equivalent) with 3 years of relevant healthcare experience in the pharmaceutical or clinical research industry.
- Strong therapeutic and protocol knowledge as provided in company training.
- 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
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Strong technical skills with CTMS, eCRF, eTMF
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ICON is the world's leading clinical research organization, providing outsourced clinical development and commercialization services to the pharmaceutical industry
