Job Summary: The Medical Writer will be an integral part of the clinical research team, primarily responsible for assisting investigators with the development and maintenance of investigator-initiated cancer clinical research protocols. This position will provide support to the Cancer Center members and the interdisciplinary Disease Sections by collaborating with individual investigators to produce high quality clinical trials assuring compliance with federal regulations.
Responsible for developing the non-scientific portions of a standard research protocol (such as registration, record-keeping and regulatory compliance sections). Collaborate with the investigator to draft non-scientific/clinical aspects including project scope. Review the entire protocol document for consistency, clarity, formatting and correct grammar. May assist with Letter of Intent and Informed Consent Form development.
Serve as primary contact for revisions to the protocol document during the submission and approval processes (including funding source, FDA, SRC, and/or IRB). Edit documents with future revisions/amendments to the study.
Prepare the summary of changes, may responding to any queries about the changes during the approval process.
Maintain and distribute updated versions of the protocol throughout the protocol life cycle.
Monitor the trial status and respond to inquiries from investigators, affiliates, supporting agencies, CTO staff, etc. Research questions regarding other aspects of trial activation and/or direct questions to the appropriate personnel. Answer questions from regulatory staff about the CTRP or ClinicalTrials.gov registration of these trials and assisting the study team at the time of results reporting to ClinicalTrials.gov.
Maintain and update protocol templates.
Periodically assist with affiliate’s activation on NU-sponsored trials.
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree; OR appropriate combination of education and experience.
Two years of relevant scientific writing experience or the equivalent combination of education, training and experience from which similar skills can be acquired.
An advanced degree (MA, MS, PhD) or the equivalent combination of education, training and experience from which comparable skills can be acquired
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
Internal Number: 37321
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.