Study Start Up Associate II

"At ICON, it's our People that set us Apart"

ICON plc, a leading global Contract Research Organization employing 15,000 people in 40 countries. ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries

As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

Profile Summary:

Provide support towards US SSU Maintenance Activities. Including but not limited to;
# Coordinating IRB Submissions & follow up for approvals.
# CTMS and Tracker Updates.
# Timely TMF QC and uploads
# Any ad hoc support towards regional deliverable deemed suitable by Sr.Management

Job Description

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Liaise with internal ICON and external (e.g. site personnel, IRBs etc.) stakeholders to deliver maintenance support activities during the clinical trial.
• Prepare, coordinate review, submit and QC submissions to ethics, regulatory and other authorities to obtain clinical trial authorizations and approvals.
• Collect critical documents for maintenance activities.
• Assist with finalization/approval of country and site Specific SIS/ ICFs in collaboration to the LIC team.
• Perform site contract negotiation including of budget and contract amendments, as required.
• Upload final documents to agreed electronic filing system (Activate, TMF, etc.) and perform updates as required to systems e.g. CTMS.
• Lead activities/ tasks and complete the deliverables within timelines, as needed.

Benefits of working at ICON:

ICON offers an exceptional benefits package that includes a comprehensive health plan, retirement plans, highly competitive pay, corporate bonus plan, time away from work, and other incentives. We provide you with the technology, innovation and resources to be successful in ensuring utmost compliance and operational efficiencies