Study Start-Up Associate II

ICON plc • Burlington, PE

3d

About The Position

Study Start- Up Associate II ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

Requirements

• BS degree or international equivalent
• 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
• Ability to explain data to facilitate decision making processes to be data driven.
• Knowledge and understanding of clinical study protocols and essential documents
• Strong organizational skills, decision making, communication and negotiation skills
• Proficient in Microsoft Excel, Word, and PowerPoint.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Responsibilities

• Contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively.
• Work directly with assigned sites on all site related essential document collection and review.
• Assist with Country level ICD preparation.
• Review and approve site level ICDs.
• Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes.
• Ensure standards are applied to the SSU processes across projects.
• Review site essential documents for start-up including but not limited to: ICF, FDF, 1572, CVs etc
• Promptly recognize and improve potential site activation delays and escalate to appropriate team members.
• Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
• Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
• Review and provide feedback to management on site performance metrics.
• Ensure accuracy and completeness of the eTMF for assigned sites during start up

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level