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We are seeking an Informed Consent/Protocol Editor for our growing Team.
Responsible for editing and writinginformed consent documents, protocols, and standard text for MSK's clinical research protocols in accordance with institutional policies, federal regulatory standards, and ease of understanding by research participants.Ensures that documents are written/edited to the expectations and standards set forth by the Protocol Activation Unit,IRB members, and research sponsors. Makes improvements to documents based on content, language, complexity, and reading level.
Edit informed consent documents, protocols, and other protocol materials for reading level (including assessment of readability), grammar, syntax, word choice and usage, consistent style, format requirements, and consistency across documents.
Fact-check and cross-check informed consent documents against protocols, re-writing as necessary, and ensuring the appropriateness of tables, charts, and figures within the documents.
Inform authors of any important missing information and inconsistencies
Assist authors with updating informed consent documents after reviews by investigators, sponsors, and MSKs IRB
Maintain editorial integrity of MSKs informed consent templates and guidance documents.Works closely with MSKs HRPP and IRB to keep current on regulatory changes and consent language best practices regarding content and approach.
Develops, writes, and manages investigational/standard medication and procedure risk libraries
Assist with training new and current Protocol Activation Managers (PAMs) on writing informed consent documents
Works independently (if applicable) on special research initiatives. Projects may include but are not limited to special requests for Research Council, IRB, Clinical Research Administration, and Office of the Physician-in-Chief or any regulatory compliance projects.
Participate and serve on Clinical Research Administration and other Institution-wide committees/projects as requested.
Bachelors degree, and at least 5 years of experience in medical writing/editing or in clinical research; Masters degree a plus.
Experience working in the pharmaceutical industry and/or consumer health publishing
Thorough knowledge of medical terminology and English grammar and syntax; knowledge of Health Literacy principles and guidelines a plus.
Experience working in a regulated environment, with at least a basic understanding of the regulations relevant to the protection of human research participants, including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations, and the Health Insurance Portability and Accountability Act (HIPAA).
Outstanding written and oral communications skills: the ability to develop timely, effective, and responsive communications with document authors, as well as with industry partners, research staff, and clinical investigators.
Ability to manage multiple priorities in a timely and effective manner.
Flexibility to work in a fast-paced, dynamic environment.
Proficiency in Microsoft Word.
Monday to Friday, 9:00 AM to 5:00 PM(Flexibility at attend occasional meetings outside these hours)
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.