Study Start Up Associate I

This is an exciting opportunity to work in ICON

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

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 in ICON

ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart. Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.