Clinical Research Coordinator II

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.

What you will be doing:

• Entry of data into Clinical Trial Management Software (CTMS).
• Generation of reports in CTMS.
• Assist Clinical Research Associates with the following clinical study related activities including but not limited to:
• Support Institutional Review Board submissions / document prep and correspondence (initial, amendments, renewals).
• Support site / study training.
• Assist in preparation of site training / study initiation materials.
• Create and maintain study binders.
• Contact and coordinate study participant recruitment and enrollment for internal trials, including:
• Retain documentation necessary for this process.
• Initiate, coordinate, and manage activities associated with external patient trials and focus group meetings, including locating participants, securing meeting locations, developing trial procedures, and designing survey materials.
• Conduct quality audits through monitoring internally and externally (remotely or onsite) to ensure compliance with US or international regulations.
• Maintain traceability and accountability of study devices.
• Follow procedures to order study equipment.
• Assist with device labeling, modified product process, set-up and shipments.
• Manager return and disposition of study equipment.
• Manager (generate and track) Purchase Orders (PO’s) to facilitate study payments to sites and vendors.
• Data Entry and Validation.
• User Assessment Testing (UAT) of Electronic Data Capture (EDC) system develop Excel spreadsheets for data capture validate / audit per validation plan.
• Initiate and track requests for legal agreements.
• Support the timely and accurate compilation of: all study data, study reports, including SAP file / document entries.
• Maintain professional relationships with internal associates.

You are:

• Bachelor’s degree preferred 
• Minimum of 2 years in clinical research or healthcare related industry, or equivalent combination of education and experience
• Experience in scientific discipline and multiple therapeutic areas preferred 
• Experience/training in the following areas: GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance), HIPAA, Drug Development and Approval Process 
• Proficiency in MS Office including Word, Excel, and PowerPoint

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, 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, colour, 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 or submit a request here.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.