Supports investigators by collaborating with internal and external stakeholders to produce high quality, scientifically sound research protocols. Assists with the strategic design, and review of LOIs (Letters Of Intent), protocols, manuscripts, and associated templates to enable successful execution and accrual on research studies. Amends or reviews study documents to implement appropriate changes during the active phase of the study. Designs protocol templates that meet required elements of FDA, NIH, NCI, and institutional review committees and other regulatory agencies. Acts as a liaison between statistical staff and investigators to ensure consistency in study design and analysis.
Provide protocol development guidance (consultation, writing, and/or editing) to investigators for investigator-initiated trials (IITs). This includes integration of required language from internal and external stakeholders, recommendations on alternative or more strategic protocol designs, and input on more efficient ways to implement processes that will streamline the logistics of protocol activities.
Lead Protocol Review Meetings with stakeholders.
Accurately apply investigators' scientific data into a cohesive format for the protocol and associated documents that are consistent with internal and external policies and regulatory requirements.
Research and remain current with protocol development-related guidance from FDA, NIH, NCI and other applicable external entities.
Inform investigators of external guidance that may affect their development strategy.
Assist in the development of study manuals/manuals of procedures that enable consistent execution of the research protocol across participating sites.
Author protocol amendments as required during the clinical trial ensuring that they minimally interfere with the ongoing clinical study and that they are consistent with internal and external policies and regulatory requirements.
Provide input on the informed consent form(s) and patient education materials as appropriate to reflect changes in the study protocol.
Perform quality assurance reviews of initial protocol documents and amendments written by investigators.
Provide protocol development related education, training and instruction as appropriate to new investigators, fellows, and any other investigator as needed.
Create and maintain standardized Protocol Templates for various types of research.
Work independently with occasional guidance from physician leadership or manager.
May perform other duties as required or assigned
Master’s or higher degree in health science or related field with relevant scientific writing experience
Working knowledge of Food and Drug Administration (FDA) requirements, Office of Human Research Protection (OHRP), International Conference of Humanization (ICH) Good Clinical Practice (GCP), as well as state and federal guidelines preferred.
Possess excellent written and oral communication skills, interpersonal skills, and be comfortable interacting with individuals at all levels internal and external to the institution.
Experience in the design and management of clinical trials and the clinical development process. Experience in oncology strongly preferred, including knowledge of cancer biology and disease processes.
Knowledge of clinical development process sufficient to effectively direct and manage multiple projects and timelines.
Proficient in standard Microsoft office applications including Word, PowerPoint Excel and other project management tools