Informed Consent Writer
PRA Health Sciences
Req #: 113752
Type: US-Southeast
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Overview: As an Informed Consent Writer you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities: What you will be doing: * Read and understand protocol-specific design, objectives, and study procedures * Prepare study-specific informed consent documents using established templates, information from protocols, content libraries and glossaries (when appropriate), and required risk language * Work with protocol authors to ensure comprehensive understanding of protocol details and the protocol approval timeline * Write, edit and review informed consent documents that reflect the principles of health literacy * Manage informed consent writing projects including the design, planning, and preparation of documentation in support of clinical development * Participate, when appropriate, in clinical trial team meetings to ensure timely delivery of the informed consent document(s) * Resolve document issues relating to informed consent * Support Global Clinical Trial Operations with informed consent process expertise and study specific support * Possible participation in the orientation and coaching of junior team members * Possible participation in initiatives to improve medical writing processes and standards * Support tool development, enhancements, and testing, as applicable * Ensure compliance with company training and time reporting Qualifications: You are: * Ability to work in a deadline-driven environment, and ability to work both independently and collaboratively with teams * Complete fluency in reading and writing American English * Excellent communication skills (email responses, meeting presentations) * Effective time management, organizational, and interpersonal skills * Customer focus * Strong project management skills Education * Life sciences degree * 3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience 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 maximise savings and plan with confidence for the years ahead * Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. 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 through the form below. https://careers.iconplc.com/reasonable-accommodations 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. #LI-JK1
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