Site Partner II/Site Specialist II
ICON
Regional United States (PRA), Unknown
Full-Time
$1,235
OfficeExecutive
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.
Site Partner II
As a Site Partner II at ICON, you will independently manage relationships with a portfolio of investigator sites, supporting their engagement and performance across studies. You will act as a trusted liaison, advocating for site needs internally while supporting ICON processes and expectations.
What You Will Do:
You will contribute to clinical research activities, taking responsibility for your deliverables and working collaboratively.
Key responsibilities include:
Building and maintaining strong relationships with assigned sites, acting as their central ICON contact across multiple studies.
Supporting sites in resolving operational issues, coordinating with internal teams to provide timely solutions.
Gathering and synthesising site feedback to inform feasibility assumptions, protocol design, and process improvements.
Monitoring site-level performance metrics and collaborating with study teams to address recruitment or quality challenges.
Contributing to the design and delivery of engagement activities and communications to enhance the site experience.
Sharing best practices with colleagues and supporting onboarding of new Site Partners as needed.
Your Profile:
You will bring relevant clinical research experience, along with the following qualifications and skills.
Required qualifications and experience:
Bachelor's degree in life sciences, healthcare, business, or a related field.
Experience in site-facing roles, site management, or clinical operations within CRO, pharma, or healthcare.
Strong communication, relationship-building, and problem-solving skills.
Good understanding of site operations and factors influencing recruitment and quality.
Organised and proactive, with the ability to manage multiple sites and competing priorities.
Collaborative team player with a commitment to delivering a high-quality site experience.
Site Specialist II
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.
What You Will Do:
Role Summary:
Support preparation, process and tracking of regulatory and site level critical documents and of site activation tasks required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable regulations/guidelines and the principles of ICH/GCP. Embrace and contribute to ICON’s culture of quality and process improvement with a focus on enhancing processes, systems and tools, adding value to our business and meeting or exceeding client needs.
Responsibilities:
Work with Site Partners and internal key stakeholders to optimize study performance and collaborate to ensure successful site activation and project outcomes.
Support Site Partners on complex or on program of studies to proficiently collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
Support collection and assembling of all documents needed in the Critical Document Package (CDP) and of those required for site activation, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable requirements and ICH/GCP guidelines.
Ensure accuracy and completeness of the Critical Document Package according to CDP checklists and timely update of the required tracking tools.
Support coordination of all necessary translations required for any start-up documentation.
Proficient in timely and accurate progress data entry of all documents collected from sites and relevant study site activation activities into the appropriate tracking systems and tools and oversee that the site activation tasks are executed according to site activation requirements.
Accurately forecast Site Activation plans and ensure they are reflected accurately in ICON’s systems, proactively follow through for achievement to plan.
Contribute to effective site activation process and timelines: participate to internal study review meetings with study teams to contribute and support risk identification to site activation, mitigation and action planning.
Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.
Your Profile:
Required qualifications and experience:
Bachelor's degree in life sciences, healthcare, business, or a related field.
3-6 years of experience in a Clinical Research environment
Relevant experience in site support, clinical administration, or similar roles within CRO, pharma, or healthcare.
Good understanding of clinical trial processes, GCP, and site documentation requirements.
Strong organizational and problem-solving skills, with the ability to manage multiple sites and priorities.
Excellent communication and interpersonal skills, with a proactive, service-focused mindset.
Comfort working independently while collaborating effectively with cross-functional teams.
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:
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