Study Start Up Associate I at ICON plc

• The employee is expected to embrace and where possible contribute to our culture of continuous process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.
• Perform timely and accurate task progress communication and data entry of all relevant study start up activities into the appropriate tracking system.
• Coordination of all necessary translations required for any start-up documentation.
• Attend study team meetings as required.

Responsible, as assigned, for one or more of the following tasks related to each of the key study start-up activities:

• Assists in identifying study sites by performing site feasibility and recruitment tasks
• Sets up and maintains site-related data in applicable clinical systems according to procedures and guidelines.
• Acts as primary site contact/liaison for study and site management issues relevant to study start-up, including addressing questions, inclusive of protocol questions, managing study supplies and accesses to applicable study systems.
• Preparation, submission, review and approval of IP Release Package (IPP)
• Essential document collection and review, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable country requirements and ICH/GCP guidelines.
• Ensure accuracy and completeness of Trial Master File (TMF) documents submitted during start-up.
• Support in forecasting site activation timelines and ensure they are reflected accurately in ICON’s systems and are achieved; work with Site Activation Lead to prepare contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified.
• Support local regulatory team with submission coordination activities, including relevant local document collection. Submission and coordination of any applicable local submissions including LEC submissions.

What You Need:

• English and Afrikaans speaker
• A high school diploma or local equivalent
• Bachelor’s Degree preferably in Life Sciences
• Minimum of 1 years’ experience or understanding of clinical study start up requirements and activities.
• Experience of Clinical Trial operations and meeting regulatory guidelines, including performing LEC submissions.