University of Utah
Research Scientist, Protocol Writer
University of Utah, Salt Lake City, Utah, United States, 84193
Job Summary
Develops research projects and is responsible for scientific design, conduct and interpretation, presenting results and publishing manuscripts. With the direction from the Institutional Protocol Development Committee ( IPDC ) at Huntsman Cancer Institute ( HCI ), the candidate will be responsible for preparing, researching, writing, and coordinating efforts related to the development of therapeutic oncology based investigator initiated clinical trials. The incumbent will be a member of the IPDC to review protocol concepts for completeness, feasibility and optimization of HCI collaborations. This position requires the necessary education and experience to provide assistance addressing complex questions about oncology clinical trial designs. Additional responsibilities include having a strong knowledge of clinical trial regulatory and compliance processes, reviewing and analyzing complex clinical trial data, generating study reports and reviewing manuscripts at trial conclusion. Serving as a member in the Research Compliance Office ( RCO ) department, the candidate may also be responsible for quality assurance oversight of clinical trials via monitoring and auditing trials and reporting study progress to the Data Safety Monitoring Committee ( DSMC ). This is a temporary full-time, benefited, (1.0 FTE ) position at Huntsman Cancer Institute. Continuation of employment will be reviewed on an ongoing basis and is contingent upon program needs, performance, and available funding. This position may be eligible for a partial hybrid schedule. Responsibilities
Assist principal investigators at HCI in the development of therapeutic oncology based investigator initiated clinical trials by merging required language from external vendors/manufacturers, with the sponsor investigator concept in the format of the institutional HCI protocol template. Responsible for researching the background, methodology, and significance of the clinical trial while providing strategic input to the overall study design. Performs scientific literature searches and reviews in support of clinical trial design, clinical evaluation reports, and the preparation of scientific manuscripts. Liaise with the principal investigator, sub-investigators, biostatisticians, translational correlative scientists, external sponsor vendors, and the clinical trials office staff to ensure a scientifically sound study protocol that is compliant with FDA , ICH GCP guidelines. Works closely with the Clinical Trials Office including the Finance, Regulatory and Specimen Processing department to ensure protocol budget is complete and funding is secured, regulatory timelines are met, and protocol manuals are drafted as applicable for the clinical trial. Create Case Report Forms (CRF’s) for investigator initiated trials. Identify data discrepancies and missing data from the CRF’s in comparison with the protocol and vice versa. Maintains 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 the protocol and draft study protocol amendments. Oversees, coordinates, and conducts 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 the 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 Recommends enhancements to standard operating policies and procedures for compliance review. Develop departmental SOPs. Work Environment and Level of Frequency that may be required
Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Sitting, hearing, listening, talking. Often: Repetitive hand motion (such as typing), walking. Seldom: Bending, reaching overhead. Minimum Qualifications
Bachelor’s degree in biology, chemistry or other scientific discipline in a related field plus four years of experience or equivalency (one year of education can be substituted for two years of related work experience) required. Demonstrated human relations and effective communication skills also required. Applicants must demonstrate the potential ability to perform the 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 the 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 Type
Benefited Staff Special Instructions Summary
Additional Information
To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affermative Action ( OEO /AA ). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/
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Develops research projects and is responsible for scientific design, conduct and interpretation, presenting results and publishing manuscripts. With the direction from the Institutional Protocol Development Committee ( IPDC ) at Huntsman Cancer Institute ( HCI ), the candidate will be responsible for preparing, researching, writing, and coordinating efforts related to the development of therapeutic oncology based investigator initiated clinical trials. The incumbent will be a member of the IPDC to review protocol concepts for completeness, feasibility and optimization of HCI collaborations. This position requires the necessary education and experience to provide assistance addressing complex questions about oncology clinical trial designs. Additional responsibilities include having a strong knowledge of clinical trial regulatory and compliance processes, reviewing and analyzing complex clinical trial data, generating study reports and reviewing manuscripts at trial conclusion. Serving as a member in the Research Compliance Office ( RCO ) department, the candidate may also be responsible for quality assurance oversight of clinical trials via monitoring and auditing trials and reporting study progress to the Data Safety Monitoring Committee ( DSMC ). This is a temporary full-time, benefited, (1.0 FTE ) position at Huntsman Cancer Institute. Continuation of employment will be reviewed on an ongoing basis and is contingent upon program needs, performance, and available funding. This position may be eligible for a partial hybrid schedule. Responsibilities
Assist principal investigators at HCI in the development of therapeutic oncology based investigator initiated clinical trials by merging required language from external vendors/manufacturers, with the sponsor investigator concept in the format of the institutional HCI protocol template. Responsible for researching the background, methodology, and significance of the clinical trial while providing strategic input to the overall study design. Performs scientific literature searches and reviews in support of clinical trial design, clinical evaluation reports, and the preparation of scientific manuscripts. Liaise with the principal investigator, sub-investigators, biostatisticians, translational correlative scientists, external sponsor vendors, and the clinical trials office staff to ensure a scientifically sound study protocol that is compliant with FDA , ICH GCP guidelines. Works closely with the Clinical Trials Office including the Finance, Regulatory and Specimen Processing department to ensure protocol budget is complete and funding is secured, regulatory timelines are met, and protocol manuals are drafted as applicable for the clinical trial. Create Case Report Forms (CRF’s) for investigator initiated trials. Identify data discrepancies and missing data from the CRF’s in comparison with the protocol and vice versa. Maintains 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 the protocol and draft study protocol amendments. Oversees, coordinates, and conducts 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 the 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 Recommends enhancements to standard operating policies and procedures for compliance review. Develop departmental SOPs. Work Environment and Level of Frequency that may be required
Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Sitting, hearing, listening, talking. Often: Repetitive hand motion (such as typing), walking. Seldom: Bending, reaching overhead. Minimum Qualifications
Bachelor’s degree in biology, chemistry or other scientific discipline in a related field plus four years of experience or equivalency (one year of education can be substituted for two years of related work experience) required. Demonstrated human relations and effective communication skills also required. Applicants must demonstrate the potential ability to perform the 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 the 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 Type
Benefited Staff Special Instructions Summary
Additional Information
To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affermative Action ( OEO /AA ). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/
#J-18808-Ljbffr