Clinical Research Associate

ICON plc

85d

About The Position

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate II in Miami, FL to support our client with Obesity trials to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

Requirements

• BA/BS/BSc in the sciences or nursing equivalent.
• A trained CRA with at least 2 years of on-site monitoring experience in phase II and phase III trials.
• Working knowledge of Electronic Data Capture (preferred).
• Experience/working knowledge of the obesity trials experience (preferred).
• Experience of Centralized/Risk Based/Targeted monitoring (preferred).
• Experience of working within a metric based environment (preferred).
• 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.

Responsibilities

• 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.
• 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.

Benefits

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees