Site Activation Lead

As a (Site Activation Lead) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• During feasibility, run GSAM Flag report to check that investigator is not on the list
• Assist in the creation, distribution and tracking of investigator feasibility questionnaires
• Follow up with sites to collect and correct feasibility questionnaires
• Collection of confidentiality disclosure agreements (CDA) from interested sites during feasibility process
• Conduct feasibility process by contacting potenztial investigational sites and collecting questionnaire data.
• Collection and review of regulatory documents for accuracy and completeness, including QC review of internal team members' review
• Conduct first line review of essential regulatory documents including FDA Form 1572, IRB approvals, financial disclosures, CVs/licensure, etc. per the Sponsor's SOPs
• Interact with site and study personnel regarding records management and site start-up activities, including follow-up on discrepancies
• Prepare final regulatory package using company's SOPs and required SOPs
• Coordination, tracking and distribution of relevant sponsor documentation prior to tRB approval (i.e. INO safely alerts) and the SIV.
• Liaise with internal personnel on trial documents and site readiness
• Obtain approval of informed consent changes so that study timelines are met
• Maintain updates and accuracy of sites information in client trial management system
• Provide Investigators with Investigator Site Binders
• Preparation and distribution of site start up materials
• Assist in the creation of initial site files for Trial Master File (TMF)
• Assist with QC audits of TMF during Start-Up period following Clients SOPs
• Assist with mentoring/training of new staff where appropriate
• Attend and participate in team meetings

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You are:

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution or a licensed health-care professional (e.g., registered nurse) required, preferably with 3 years relevant clinical research experience.

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.