Senior Clinical Research Associate
hace 1 mes
We are seeking a highly skilled and experienced Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for coordinating all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations, and standard operating procedures.
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 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.
- Collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely.
- Review "source to CRF/eCRF," ensuring patient safety and data integrity aspect of the study.
- Escalate any concerns/issues to other departments, including Safety, Investigational Medicinal Product, Local Study Managers, and management team as appropriate.
- Oversee the sites' adherence to GCP/ICH practices, ensuring quality of study conduct.
- 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.
- 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.
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.
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.
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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON, whether it is for this or other roles.
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