ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.Responsibilities:Run and assist with running Micro Strategy Reports for impact.During feasibility run GSAM Flag report to ensure 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 potential 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 Bayer'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 to ensure study timelines are met.Maintain updates and ensure 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.Qualifications:Education required: Bachelors degree in a business-related, health, life sciences or other relevant field of study.Experience Required: 4 years relevant experience including 1 year in a leadership capacity.Benefits of Working in ICON: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. At 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.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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
#J-18808-Ljbffr