Tasks Responsible for developing, reviewing, finalizing, and maintaining clinical trial documents such as informed consent forms. Apply knowledge of GCP Guidelines, regulatory requirements, privacy standards, biological samples standards, therapeutic areas, and Investigational Medicinal Products (IMPs) to review and develop Informed Consent Forms (ICF). Ensure that the content of the Master Informed Consent Form aligns with the protocol and fully informs potential research subjects about the study to aid their decision-making. Guarantee that the consent forms are understandable, using clear language accessible to participants, including scientific and medical terminology. Write and edit documents in compliance with global industry standards. Incorporate client-specific guidance and requirements into the Master Informed Consent Form during development and review. Support the development, review, and approval of master templates to facilitate protocol and site activation. Create, review, and revise training materials and plans to meet team training needs. Communicate timely and appropriately with all stakeholders regarding project status, issues, or safety concerns. Liaise with Project Managers or designees to report trends, outstanding issues, or safety concerns that could impact trial delivery or patient safety. Skills Strong knowledge of the drug development process. Good understanding of FDA IND/NDA requirements. Comprehensive understanding of regulations related to clinical trials, including FDA regulations, biological samples, GDPR, and GCP guidelines. Knowledge of medical terminology and health literacy principles is advantageous. Excellent customer service and management skills. Proficiency in MS Word and other relevant computer skills. Excellent command of English, both written and verbal. Ability to influence stakeholders through industry insights. Strong planning, prioritization, and timely delivery skills. Attention to detail and commitment to high-quality work. Negotiation, mentoring, and training abilities. Adaptability to a fast-paced, dynamic environment. Requirements University or College Degree; a medical degree is preferred. Minimum of 5 years experience in writing and editing clinical trial documents, including informed consent forms. Advanced proficiency in English (oral and written). Strong knowledge of ICH-GCP guidelines and applicable regulations. Candidates without a medical or life sciences background but with relevant domain knowledge and experience may be considered. Learn more about our EEO & Accommodations request here . #J-18808-Ljbffr