The Protocol Writer supports University researchers from various departments in taking concepts and moving them into fully developed clinical protocols. This role collaborates with the study team to develop scientifically sound, feasible clinical protocols. In addition, this position may be responsible for other clinical deliverables including, but not limited to, protocol amendments and facilitating the development of the Investigator’s Brochures with the PI and regulatory team.
Compiles, writes, and edits medical writing deliverables covering all phases of clinical research and various therapeutic areas.
Serves as a medical writer on project teams with minimal supervision. Works with researchers in writing, developing and producing final versions of clinical research protocols.
Collaborates with researchers, study teams, stakeholders and clinical partners, as well as other cooperative groups (as required), and coordinates communication between these groups to assure required protocol development timelines are met.
Coordinates the internal review of documents.
Creates writing deliverables that include, but may not be limited to:
Clinical study protocols and clinical protocol amendments
Facilitate the development of Investigator’s Brochures with the PI and regulatory team.
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
Interacts with stakeholders in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
Collaborates with Research Preparation Group for feedback on logistics and feasibility of protocol.
Adheres to established regulatory standards as well as Standard Operating Procedures.
Assists with on-line clinical literature searches, as requested.
Maintains familiarity with current regulatory requirements and guidelines that affect medical writing.
Develops protocol content that contains best practice and/or standard language adhering to regulatory and institutional requirements.
Collaborates with IRB to provide feedback and input on enhancements to institutional protocol templates.
Participate as key stakeholder in institutional initiatives related to protocol development.
BA/BS in a health related field with at least 6 years of extensive clinical and/or translational research processes experience or an advanced degree with 4 years of extensive clinical and/or translational research processes experience.
At least 3 years of experience in technical writing experience including protocols, grants, or other documents related to scientific research.
Knowledge of clinical research regulations and guidance, e.g. informed consent process, adverse event reporting, the Code of Federal Regulations (including but not limited to 21 CFR 312 and 812), ICH GCP, and HIPAA regulations.
Knowledge of Microsoft Office applications with particular proficiency in Word, with the ability to learn new software, as needed.
Knowledge of medical terminology.
Excellent written and verbal communication skills.
Experience in an Academic Medical Center
Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), or Regulatory Affairs Certification (RAC) or qualified to sit
Internal Number: 323685
About University of Minnesota
The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.
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