Site Specialist II

Site Specialist II - Remote - US

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

ICON is hiring for Site Specialist II and Sr. Site Specialist

Title: Site Specialist II

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.

What you need:

• Bachelor’s Degree

• 3-6 years of experience in a Clinical Research environment

• Demonstrate good organizational skills, ability to prioritize tasks and to deal with competing priorities

• Good computer and Microsoft office knowledge

• Completes tasks independently on time and in an efficient manner.

• Ability to support other Site Specialists as needed.

• Demonstrate ability to deal with internal stakeholders.

• Demonstrate ability to identify study and site risks and properly document in tracking and reporting tools; support action planning with other study team stakeholders.

Title: Senior Site Specialist

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.  Act as Subject Matter Expert and embrace 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:

• Recognize, exemplify and adhere to ICON’s values of Accountability and Delivery, Collaboration, Partnership and Integrity, which center around our commitment to Ownership.

• Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.

• Work with Site Partners and internal key stakeholders to optimize study performance and collaborate to dirve successful site activation and project outcomes.

• Support the set up of internal tracking tools needed for site activation to enable effective tracking of progress according to site activation requirements.

• Serves as internal consultant to optimize site activation work and tool set up

• Act as primary point of contact on high volume studies or on study programs to coordinate the activities of Site Activation Specialists and to support execution of Site Activation to plan.

• Support training and onboarding of more junior Site activation specialists, if assigned on the same studies.

• 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.

• 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 and support risk identification to site activation, mitigation and action planning.

• Proficiently drive Site activation duties per assigned studies and sites and that include:

  • To support Site Partners 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.

  • To 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.

  • To ensure accuracy and completeness of the Critical Document Package according to CDP checklists and timely update of the required tracking tools.

  • To support coordination of all necessary translations required for any start-up documentation.

  • To proficiently perform 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.

What you need:

• Bachelor's Degree

• 3-6 years of experience in a Clinical Research environment

• Demonstrate proficient organizational skills and ability to prioritize tasks with minimal management support and oversight.

• Exhibits extensive competency in Microsoft Office Suite applications (i.e. Word, Excel, Powerpoint, Outlook).

• Completes tasks independently on time and in an efficient manner.

• Ability to mentor and train other site specialistis as needed.

• Show confidence in dealing with internal stakeholders.

• Show ability to identify study and site risks and properly document in tracking and reporting tools; support action planning with other study team stakeholders.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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