# Site Specialist II

**Company**: ICON
**Work arrangement**: hybrid
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Peru-Lima/Site-Specialist-II_JR159364?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_da519ab5-855

## Description

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 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.

**Key Responsibilities:**

- 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.

**Rewards & 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.

## Skills

### Required
- clinical research
- regulatory affairs
- ICH-GCP
- project management
- English
- Spanish

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