Clinical Study Coordinator

Job title: Clinical Study Coordinator

About the Role ICON is seeking a Clinical Study Coordinator to design and analyze clinical trials, interpret complex medical data, and contribute to the advancement of innovative treatments and therapies. The role involves delivering clinical research work to a high standard, collaborating with team members and stakeholders to drive excellence in clinical development.

What You'll Do

• Complete and maintain study regulatory binder and documents including, but not limited to, training documentation, screening and enrollment logs, and investigational product accountability and device usage logs.
• Host/facilitate oversight check-in visits.
• Assign, maintain, and communicate user codes.
• Assign and communicate accurate subject numbers with all study staff.
• Conduct and document the informed consent process, perform pseudo-randomization of scans, and maintain results blinding between users.
• Ensure that all demographic information is accurately recorded on the Case Report Form (CRF) and that Estimated Date of Delivery (EDD) is captured on CRF prior to end of subject’s appointment.
• Ensure the users enter the right code and subject number on each study device prior to the start of each scan.
• Ensure that all CRFs, protocol deviations, device deficiencies, and AEs are captured by the responsible parties before moving to the next appointment.
• Ensure 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.
• Ensure all study devices are connected to Wi-Fi, properly stored, and charged at the end of each day.
• Schedule and issue reminders for follow-up visit(s), and complete 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 using the provided 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.

What We're Looking For

• Bachelor's degree in a relevant scientific discipline.
• 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.

Compensation & Benefits

• Competitive salary and annual leave entitlements.
• Health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of professionals for well-being support.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
• ICON is committed to inclusion and providing an accessible environment for all candidates.