Clinical Study Coordinator
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a Clinical Study Coordinator at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.
What You Will Do:
Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders.
Key responsibilities include:
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:
You will bring relevant clinical research experience, along with the following qualifications and skills.
Required qualifications and experience:
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.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here .
Salary Range
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