Study Start Up Associate II (Supporting North America region - US/CAN)

About the Role

ICON is seeking a Study Start Up Associate II (Site Activation Partner) to support the initiation of clinical trials in North America. You will lead or support start-up activities, ensure regulatory compliance, and help activate investigator sites within study timelines and Sponsor standards. What You'll Do

• Initiate and coordinate start-up activities and essential documents to compile a high-quality Investigator Initiation Package (IIP) for site initiation approval.

• Support the compilation of the Central Investigator Review Board (IRB) package and submissions for study approval (where applicable) and other committees as per country requirements.

• Prepare, validate, and submit regulatory documents such as completed IIP, IRB approval forms, and FDA 1572/Attestation Form within required timelines.

• Support investigators' sites with local IRB workflow from preparation through approval.

• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines.

• Maintain ongoing contact with the study team and respond promptly to study team and investigator site requests.

• Coordinate and liaise with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.

• Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence.

• Provide guidance and support to study teams on regulatory requirements and best practices for start-up activities.

• Participate in process improvement initiatives to streamline start-up processes and enhance efficiency. What We're Looking For

• Bachelor’s degree in life sciences or related field.

• Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.

• Very good level of English; experience working with the US market (NAM).

• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.

• Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Nice to Have

• (No additional optional qualifications mentioned in the posting.) Compensation & Benefits

• Competitive salary (USD) with a range aligned to market and experience.

• Various annual leave entitlements.

• Health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings.

• Global Employee Assistance Programme (LifeWorks) with 24-hour access to support.

• Life assurance.

• Flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, gym memberships, discounted travel passes, health assessments, etc.).

• ICON is committed to inclusion and belonging and provides equal opportunity for all qualified applicants.