Site Specialist II

Site Specialist 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 Site Specialist II at ICON, you will independently manage a range of site support activities, acting as a key operational contact for sites and contribute to efficient study start-up and maintenance.

You will take responsibility for site management and operations deliverables, applying your skills to ensure quality and efficiency.

Key responsibilities include:

• Coordinating site-level document collection, review, and maintenance, ensuring accuracy and compliance for assigned sites or studies.

• Acting as an operational liaison for site staff on documentation, systems, and process-related questions.

• Maintaining up-to-date site status, metrics, and key milestones in clinical trial management tools.

• Supporting planning and logistics for site meetings, investigator meetings, and monitoring visits.

• Identifying opportunities to streamline site workflows and contributing to process improvement initiatives.

• Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.

• Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.

• Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence

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

• Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Your Profile:

• Bachelor's degree in life sciences, healthcare or a related field, and clinical research experience.

• Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities (local and/or international regulatory processes, including submissions to regulatory authorities and ethics committees)..

• 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, and to collaborate effectively with cross-functional teams in a fast-paced environment.

• Excellent communication skills both in English and Spanish

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply