Job Information

University of Utah Research Scientist Protocol Writer in Salt Lake City, Utah

Details

Open Date 05/03/2022

Requisition Number PRN30407B

Job Title Research Scientist

Working Title Research Scientist Protocol Writer

Job Grade F

FLSA Code Professional

Patient Sensitive Job Code? No

Standard Hours per Week 40

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

VP Area President

Department 01345 - HCI Clinical Resrch Compliance

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 60000 to 90400

Close Date

Open Until Filled Yes

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 ).

Huntsman Cancer Institute ( HCI ) is an Equal Opportunity Employer committed to hiring individuals whose merit and experience promote a diverse, inclusive, anti-racist workforce and culture.

Each employee has a unique background and life experience. We believe that maximizing diversity fuels the success of our organization. In your cover letter or during your interview, we invite you to share how your background, beliefs, and experience will prepare you to be effective in working in an environment that values diversity and is committed to equity, diversity, and inclusion.

Learn more about HCI’s commitments at huntsmancancer.org/edi and/or contact HCI’s Office of Equity, Diversity, and Inclusion.

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.

Minimum Qualifications

Bachelor’s degree in biology, chemistry or other scientific discipline in a related field plus four years of experience or equivalency 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.

Preferences

· 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

The University of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.

Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.

The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.

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 Affirmative Action:

Director/ Title IX Coordinator

Office of Equal Opportunity and Affirmative Action ( OEO /AA)

135 Park Building

Salt Lake City, UT 84112

801-581-8365

oeo@utah.edu

Online reports may be submitted at oeo.utah.edu

For more information: https://www.utah.edu/nondiscrimination/

To inquire about this posting, email: employment@utah.edu (%20employment@utah.edu) or call 801-581-2300.

The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.

This position may require the successful completion of a criminal background check and/or drug screen.