Clinical Study Specialist (hybrid/Office-based - Warren, NJ or Cambridge MA)

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

• Organizes and delivers analyzable reports and metrics to the clinical study lead

• Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings

• Collates data for assessments such as feasibility and site selection and reviews site usability database

• Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures

• Compiles 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 binders

• Collates materials for training and investigator meetings

• Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan

• Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings

• Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance

• Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)

• Manages and maintains team SharePoint and/or shared drive sites, as needed

• Communication with sites as directed and maintains site contact information

• Contributes 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 visits

• Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives

• Proactively recommends process improvement initiatives for the department

Your profile

• Must have a Bachelor's Degree

• Must have a minimum of 2 years industry related work experience

• Experience supporting global trials (NA, LAM, EU, APAC, India)

• Experience working in TMF, CTMS, Sharepoint,

• Excels in written and verbal communications

• Self-starter, can work independently with minimal oversight, solution-oriented

• ICF review experience

• General competency: powerpoint/excel skills, meeting minutes

• Vendor management/oversight experience a plus

• Must be open to hybrid office/home based in Warren NJ, Armonk NY or Cambridge MA

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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