Clinical Study Coordinator

About the role

ICON plc is a world-leading healthcare intelligence and clinical research organization. We 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.

Key Responsibilities

• Completing and maintaining study regulatory binder and documents including, but not limited to, training documentation, screening and enrollment logs, and investigational product accountability and device usage logs.
• Hosting/facilitating oversight check-in visits.
• Assigning, maintaining, and communicating user codes.
• Assigning and communicating accurate subject numbers with all study staff.
• Conducting and documenting the informed consent process, performing pseudo-randomization of scans, and maintaining results blinding between users.
• Ensuring that all demographic information is accurately recorded on the Case Report Form (CRF).
• Confirming that Estimated Date of Delivery (EDD) is captured on CRF prior to end of subject’s appointment.
• Ensuring the users enter the right code and subject number on each study device prior to the start of each scan.
• Ensuring that all CRFs, protocol deviations, device deficiencies, and AEs are captured by the responsible parties before moving to the next appointment.
• Ensuring that subject demographics are transcribed by the data coordinators within 72 hours of enrollment and all Visit 1 eCRFs as well as image uploads are completed within five (5) days of enrollment.
• Ensuring all study devices are connected to Wi-Fi, properly stored, and charged at the end of each day.
• Scheduling and issuing reminders for follow-up visit(s), and completing follow-up medical history documentation, within three (3) months post-delivery.
• Ensuring follow-up data is transcribed into Medidata within five (5) days of the visit.
• Maintaining a complete log and secure electronic backup copies of all data and reports on the laptop.
• Responsible for maintaining segregation between the paper CRF, Medidata eCRF data entry, and image uploads.
• All study data must be de-identified and verified by the site prior to upload into Medidata.
• Source data for research-specific procedures must be recorded on paper at the time the procedure is performed. Sites will be provided paper Source Document Template forms that mirror the Medidata eCRF. These templates must be used to capture source data for subsequent transcription into Medidata.
• Perform a secondary completeness and accuracy check of each paper CRF prior to data entry.
• Transcribe all data from the paper source documents into Medidata in a timely manner.
• Upload scanned copies of completed CRFs into Medidata.
• Transfer all study images from device tablets to the designated laptop.

Your Profile

• Relevant clinical research experience.
• Proven experience as a Clinical Study Coordinator or in a similar role.
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Strong organizational and multitasking skills.
• Excellent communication and interpersonal abilities.

What ICON Can Offer You

• Variety of 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.