The Site Activation Specialist is responsible for site start-up activities for the assigned studies within the Site Alliance and Site Activation Sub-Chapter under Clinical Operations. The position will require strong stakeholder management working closely with Contracting, IVDR, Legal, Privacy, Study Teams, CRO, and Sites.

What you will be doing:

● Responsible for the effective operations and delivery of site activation deliverables across all regions, within the assigned projects.

● Supports the pre-study site identification/selection process for relevant studies through collection and analysis of site feasibility information.

● Maintain regular communications with investigational sites/CRO to ensure timely completion of the required site activation activities/documentation and resolve or escalate issues in a timely manner

● Collect, receive and perform the first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines, and study timelines and requirements

● Coordinate Investigator Review Board (IRB)/Ethics Committee (EC)/other relevant regulatory submissions in collaboration with sites/study teams

● Work with sites to ensure informed consent form meets the required regulatory and company requirements.

●Facilitate the translation of essential documents that may be required in languages other than English for the purposes of submission to and approval from Competent Authorities and/or IRB/EC.

● Coordinate the clinical trial insurance process to ensure timely results and support throughout the conduct of the clinical study.

● Support contract and budget negotiations in partnership with Contracting and Study Teams.

● Ensure Purchase orders and Fair Market Value assessments are completed for timely start-start up.

● Support study instrument placements, Obtain import/export licensure

● Support implementation and use of eTools at the site

● Collect and maintain relevant country, local, state, and site-level regulatory intelligence for future use

● Work closely with Study Teams to deliver study start-up tasks.

● Solve identified issues with appropriate timely escalation to the Study Teams

● Support internal audit and external inspection activities; contribute to CAPAs as required.

● May be responsible for other responsibilities as assigned.

You are:

● Associate or Bachelor’s degree in chemistry, biology, other life sciences, or a related field, or equivalent combination of education and experience

● Experience in study start-up is required

● Experience with CRO management is a plus.

● Experience in clinical trial planning, including IRB/Ethics Committee, Competent authority submissions and contracts

● Knowledge of clinical trial methodologies, medical terminology, ICH/GCP

● Must be fluent in English, and the language of the appointed location

● Working knowledge of global and local regulatory requirements (IVDR and other applicable regulations) is a plus.

● Understand the quality expectations and emphasis on the right first time, attention to detail

● Ability to organize tasks, time, and priorities, ability to multi-task

● Required to support multi-national team members, and flexibility in working hours may be needed.

● Participate and work effectively with multiple cross-functional teams

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.

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.