University of Utah
Priority Review Date
Note - Posting may close at any time. 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. Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve – which includes Idaho, Montana, Nevada, Utah, and Wyoming – with impact worldwide. In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute’s mission and this position. 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 Physical Requirements
Office environment, nearly continuously. Sitting, hearing, listening, talking. Often repetitive hand motion such as typing, walking. Minimum Qualifications
Bachelor’s degree in biology, chemistry or other scientific discipline in a related field plus four years of experience or equivalence (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 FDA requirements, Office of Human Research Protection (OHRP), 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. Posting Specific Questions
Do you have a related Bachelor's degree or equivalency? (2 years related work experience may be substituted for 1 year of education)
Yes No
Indicate the number of years of experience that you have in developing scientific research projects, acting as principal or co-principal investigator, managing a research staff, and/or delivering formal presentations or educational seminars:
Less than 2 years 2 year or more, but less than 4 years 4 years or more, but less than 6 years 6 years or more, but less than 8 years 8 years or more
Do you have any current relatives working in HCI? (Open Ended Question) Required Documents
Resume Optional Documents
Cover Letter
#J-18808-Ljbffr
Note - Posting may close at any time. 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. Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve – which includes Idaho, Montana, Nevada, Utah, and Wyoming – with impact worldwide. In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute’s mission and this position. 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 Physical Requirements
Office environment, nearly continuously. Sitting, hearing, listening, talking. Often repetitive hand motion such as typing, walking. Minimum Qualifications
Bachelor’s degree in biology, chemistry or other scientific discipline in a related field plus four years of experience or equivalence (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 FDA requirements, Office of Human Research Protection (OHRP), 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. Posting Specific Questions
Do you have a related Bachelor's degree or equivalency? (2 years related work experience may be substituted for 1 year of education)
Yes No
Indicate the number of years of experience that you have in developing scientific research projects, acting as principal or co-principal investigator, managing a research staff, and/or delivering formal presentations or educational seminars:
Less than 2 years 2 year or more, but less than 4 years 4 years or more, but less than 6 years 6 years or more, but less than 8 years 8 years or more
Do you have any current relatives working in HCI? (Open Ended Question) Required Documents
Resume Optional Documents
Cover Letter
#J-18808-Ljbffr