University of Utah
Research Scientist, Protocol Writer
University of Utah, Salt Lake City, Utah, United States, 84193
Job Summary
Research Scientist, Protocol Writer role at University of Utah. Develops research projects and is responsible for scientific design, conduct, interpretation, presenting results and publishing manuscripts. With direction from the Institutional Protocol Development Committee (IPDC) at Huntsman Cancer Institute (HCI), prepares, researches, writes and coordinates efforts related to development of therapeutic oncology investigator‑initiated clinical trials. Member of IPDC to review protocol concepts for completeness, feasibility and optimization of HCI collaborations. Provides assistance addressing complex questions about oncology clinical trial designs. Strong knowledge of clinical trial regulatory and compliance processes, reviews and analyzes complex clinical trial data, generates study reports and reviews manuscripts at trial conclusion. Serves as member in the Research Compliance Office (RCO) department, responsible for quality assurance oversight of clinical trials via monitoring and auditing trials and reporting study progress to the Data Safety Monitoring Committee (DSMC). Temporary full‑time, benefited (1.0 FTE) position at Huntsman Cancer Institute. Continuation of employment reviewed on ongoing basis and contingent upon program needs, performance and available funding. May be eligible for a partial hybrid schedule. Responsibilities
Assist principal investigators at HCI in development of therapeutic oncology investigator‑initiated clinical trials by merging required language from external vendors/manufacturers with sponsor investigator concept in institutional HCI protocol template. Research background, methodology and significance of clinical trial while providing strategic input to overall study design. Perform scientific literature searches and reviews in support of clinical trial design, clinical evaluation reports and preparation of scientific manuscripts. Liaise with principal investigator, sub‑investigators, biostatisticians, translational correlative scientists, external sponsor vendors and clinical trials office staff to ensure scientifically sound study protocol that is compliant with FDA, ICH GCP guidelines. Work closely with Clinical Trials Office including Finance, Regulatory and Specimen Processing department to ensure protocol budget is complete and funding secured, regulatory timelines met and protocol manuals drafted as applicable. Create Case Report Forms (CRFs) for investigator‑initiated trials. Identify data discrepancies and missing data from CRFs compared with protocol and vice versa. Maintain current knowledge regarding federal and state guidance, including Good Clinical Practice (GCP). Track study progress including monitoring enrollment, dose escalation, data completion and validation. Recognize protocol deviations and modifications needed for protocol and draft study protocol amendments. Oversee, coordinate and conduct monitoring of clinical research studies as needed. Acquire and abstract primary or secondary data from existing internal or external data sources and conduct clinical analysis of the data. Assist in development, implementation and optimization of data collection systems and other strategies that enhance data quality and completeness. Organize and interpret data to develop recommendations based on findings. Create or manage creation of any type of clinical research reporting document such as manuscripts, posters or oral presentations to present data objectively in a clear, concise format. Recommend enhancements to standard operating policies and procedures for compliance review. Develop departmental SOPs. Work Environment and Frequency
Nearly continuously: Office environment. Physical Requirements and Frequency
Nearly continuously: Sitting, hearing, listening, talking. Often: Repetitive hand motion (typing), walking. Seldom: Bending, reaching overhead. Minimum Qualifications
Bachelor's degree in biology, chemistry or related scientific discipline plus four years of experience or equivalency (one year of education can be substituted for two years of related work experience). Demonstrated human relations and effective communication skills also required. Applicants must demonstrate potential ability to perform essential functions of the job as outlined in the position description. Preferred Qualifications
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. Knowledge of clinical trial methodology and development to effectively direct and manage multiple projects and timelines. Strong attention to detail, establishing priorities and adhering to deadlines. Experience in management of clinical trials and the clinical development process. Oncology clinical trial experience highly preferred. Able to exercise appropriate judgment within generally defined practices and policies in selecting method for obtaining solutions. Able to show initiative and work independently, take initiative and complete tasks to meet deadlines. Excellent interpersonal communication (including oral and written) and leadership skills also required. Proficient in standard Microsoft office applications including Word, PowerPoint, Excel and other project management tools. SOCRA or ACRP certification. Requisition Number
PRN43309B Full Time or Part Time?
Full Time Location
Campus Pay Rate Range
47,600 to 80,000 Close Date
12/31/2025 Open Until Filled
Open Until Filled To Apply
To apply, visit https://utah.peopleadmin.com/postings/190308
#J-18808-Ljbffr
Research Scientist, Protocol Writer role at University of Utah. Develops research projects and is responsible for scientific design, conduct, interpretation, presenting results and publishing manuscripts. With direction from the Institutional Protocol Development Committee (IPDC) at Huntsman Cancer Institute (HCI), prepares, researches, writes and coordinates efforts related to development of therapeutic oncology investigator‑initiated clinical trials. Member of IPDC to review protocol concepts for completeness, feasibility and optimization of HCI collaborations. Provides assistance addressing complex questions about oncology clinical trial designs. Strong knowledge of clinical trial regulatory and compliance processes, reviews and analyzes complex clinical trial data, generates study reports and reviews manuscripts at trial conclusion. Serves as member in the Research Compliance Office (RCO) department, responsible for quality assurance oversight of clinical trials via monitoring and auditing trials and reporting study progress to the Data Safety Monitoring Committee (DSMC). Temporary full‑time, benefited (1.0 FTE) position at Huntsman Cancer Institute. Continuation of employment reviewed on ongoing basis and contingent upon program needs, performance and available funding. May be eligible for a partial hybrid schedule. Responsibilities
Assist principal investigators at HCI in development of therapeutic oncology investigator‑initiated clinical trials by merging required language from external vendors/manufacturers with sponsor investigator concept in institutional HCI protocol template. Research background, methodology and significance of clinical trial while providing strategic input to overall study design. Perform scientific literature searches and reviews in support of clinical trial design, clinical evaluation reports and preparation of scientific manuscripts. Liaise with principal investigator, sub‑investigators, biostatisticians, translational correlative scientists, external sponsor vendors and clinical trials office staff to ensure scientifically sound study protocol that is compliant with FDA, ICH GCP guidelines. Work closely with Clinical Trials Office including Finance, Regulatory and Specimen Processing department to ensure protocol budget is complete and funding secured, regulatory timelines met and protocol manuals drafted as applicable. Create Case Report Forms (CRFs) for investigator‑initiated trials. Identify data discrepancies and missing data from CRFs compared with protocol and vice versa. Maintain current knowledge regarding federal and state guidance, including Good Clinical Practice (GCP). Track study progress including monitoring enrollment, dose escalation, data completion and validation. Recognize protocol deviations and modifications needed for protocol and draft study protocol amendments. Oversee, coordinate and conduct monitoring of clinical research studies as needed. Acquire and abstract primary or secondary data from existing internal or external data sources and conduct clinical analysis of the data. Assist in development, implementation and optimization of data collection systems and other strategies that enhance data quality and completeness. Organize and interpret data to develop recommendations based on findings. Create or manage creation of any type of clinical research reporting document such as manuscripts, posters or oral presentations to present data objectively in a clear, concise format. Recommend enhancements to standard operating policies and procedures for compliance review. Develop departmental SOPs. Work Environment and Frequency
Nearly continuously: Office environment. Physical Requirements and Frequency
Nearly continuously: Sitting, hearing, listening, talking. Often: Repetitive hand motion (typing), walking. Seldom: Bending, reaching overhead. Minimum Qualifications
Bachelor's degree in biology, chemistry or related scientific discipline plus four years of experience or equivalency (one year of education can be substituted for two years of related work experience). Demonstrated human relations and effective communication skills also required. Applicants must demonstrate potential ability to perform essential functions of the job as outlined in the position description. Preferred Qualifications
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. Knowledge of clinical trial methodology and development to effectively direct and manage multiple projects and timelines. Strong attention to detail, establishing priorities and adhering to deadlines. Experience in management of clinical trials and the clinical development process. Oncology clinical trial experience highly preferred. Able to exercise appropriate judgment within generally defined practices and policies in selecting method for obtaining solutions. Able to show initiative and work independently, take initiative and complete tasks to meet deadlines. Excellent interpersonal communication (including oral and written) and leadership skills also required. Proficient in standard Microsoft office applications including Word, PowerPoint, Excel and other project management tools. SOCRA or ACRP certification. Requisition Number
PRN43309B Full Time or Part Time?
Full Time Location
Campus Pay Rate Range
47,600 to 80,000 Close Date
12/31/2025 Open Until Filled
Open Until Filled To Apply
To apply, visit https://utah.peopleadmin.com/postings/190308
#J-18808-Ljbffr