Clinical Research Associate- Early Development - Northeast
- Boston
- Clinical Monitoring
- ICON Strategic Solutions
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please click here to view live vacancies.
ICON is looking for a Clinical Research Associate in Northeast Region who has experience in Phase I Oncology Studies !
What you will be doing:
- Conduct clinical trial site visits including evaluation, initiation, monitoring and close out
- Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems
- Proactive site management including:
- Building and maintaining solid and professional relationships with site staff
- Facilitating subject enrolment incorporating recruitment strategies and action plans at site level
- Maintaining site audit/inspection readiness
- Ensuring appropriate safety reporting and use of on-line safety reporting/reviewing systems such as Intralinks
- Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan
- Responding to site queries and escalating issues in accordance with processes and timelines
- Conducting IP accountability and reconciliation
- Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
- Maintenance of site study supplies
Operational Excellence:
- Contribute to sponsor goals
- Promote operational and scientific excellence
- Identify opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness.
You are:
- BA/BS/BSc in the sciences or nursing equivalent
- A trained CRA with on-site monitoring experience
- Comprehensive knowledge and understanding of ICH-GCP
- Fluent oral (face to face and telephone) and written English language skills
- Able and willing to travel up to 60% of the time or as per local requirements
- Possession of a full driver’s license
- Able and willing to work from a designated and appropriate home office as per local requirements
- Willing to attend and contribute to team meetings including mandatory training (remote/off-site)
- Competent computer skills including working knowledge of common software packages
- Working knowledge of trial management databases and on-line systems
- Able to attend a 1 week face to face in-house training course as part of on-boarding training
- Able and willing to work on several protocols/therapy areas
- Experience in phase II and phase III trials (preferred)
- Working knowledge of Electronic Data Capture (preferred)
Experience/working knowledge of the oncology disease area (preferred)
- Experience of Centralized/Risk Based/Targeted monitoring (preferred)
- Experience of working within a metric based environment (preferred)
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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