Clinical Study Specialist Posted Date 11 hours ago(7/30/2025 3:10 PM) ID 2025-121214 Location : Location US-Remote Overview
As a Clinical Study Support Specialist, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What you will be doing:
Organizes and delivers analyzable reports and metrics to the clinical study leadSchedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetingsCollates data for assessments such as feasibility and site selection and reviews site usability databaseContributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating proceduresCompiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory bindersCollates materials for training and investigator meetingsTracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring planMonitors and updates investigator/site status for the trial, and supports with clinical trial registry postingsPerforms scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidanceEnsures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)Manages and maintains team SharePoint and/or shared drive sites, as neededCommunication with sites as directed and maintains site contact informationContributes to line listings review for Blind Data Review Meeting (BDRM)May manage or contribute to oversight of Third Party Vendors (TPV)Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visitsParticipates in Standard Operating Procedures (SOPs) revisions or departmental initiativesProactively recommends process improvement initiatives for the department Qualifications
You are:
Must have a Bachelor's DegreeMust have a minimum of 2 years industry related work experienceExperience supporting global trials (NA, LAM, EU, APAC, India)Experience working in TMF, CTMS, Sharepoint,Excels in written and verbal communicationsSelf-starter, can work independently with minimal oversight, solution-orientedICF review experienceGeneral competency: powerpoint/excel skills, meeting minutesVendor management/oversight experience a plusEST time preferred
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 entitlementsA range of health insurance offerings to suit you and your family’s needsCompetitive retirement planning offerings to maximise savings and plan with confidence for the years aheadGlobal 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-beingLife assuranceFlexible 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/benefits
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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.
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