1 Research Mgr, Protocol Management Job in Salt Lake, UT
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Research Mgr, Protocol Management
$107k-137k (estimate)
Full Time | Colleges & Universities
6 Months Ago
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University of Utah is Hiring a Research Mgr, Protocol Management Near Salt Lake, UT
The Clinical Research Compliance Manager in the Research Compliance Office (RCO) at Huntsman Cancer Institute is responsible for the management and oversight of the Investigator-Initiated Trial (IIT) Protocol Management team. The Protocol Management team consists of group of individuals with varying expertise ranging from clinical trial study start up activities (feasibility, regulatory, protocol writing, budget/contracts etc.) to final clinical study close out (data validation and analysis, manuscript writing support, etc.). Timely activation, along with a well-written protocol that can be carried out compliantly and efficiently remains a high priority for the IIT protocol management team. The Clinical Research Manager will support and foster strong team collaboration and increased efficiencies to facilitate the success of our IITs at HCI. The position reports to the Director of Research Compliance Office and collaborates with partner departments including the Clinical Trials Office, Population Science Trials Office, Institutional Review Board, Office of Sponsored Projects, Office of General Counsel, etc.
HuntsmanCancer 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. Partnerships with individuals, communities, and many other entities are crucial to our work. Huntsman Cancer Institute values cancer-related health equity, diversity, and inclusion as integral to our guiding principle to serve our patients and their communities, and our commitment to foster a culture of belonging for all within our organization.
HuntsmanCancer 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. Partnerships with individuals, communities, and many other entities are crucial to our work. Huntsman Cancer Institute values cancer-related health equity, diversity, and inclusion as integral to our guiding principle to serve our patients and their communities, and our commitment to foster a culture of belonging for all within our organization.
In your cover letter or during your interview process, we invite you to share how your personal and 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.
Learn more: https://healthcare.utah.edu/huntsmancancerinstitute/about-us/equity-diversity-inclusion
Responsibilities
Completion of provided supervisory training within one year of employment may be required.
Master’s degree in a related area may be preferred.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
Essential Functions:
Essential Functions:
Please include a cover letter with your application detailing your interest and qualifications for this position.
- Provide protocol management support by reviewing all newly written IITs in preparation for, IPDC, FAR, PRMC, and DSMC to ensure compliance with institutional policies as well as the FDA, OHRP, IRB, ICH GCP, state and federal regulations.
- Reviews amendments for any inconsistencies, formatting issues, and inclusion of all required elements throughout the protocol.
- Promotes collaborations across groups to ensure all involved parties review and approve newly written protocols as well as protocol amendments.
- Reviews electronic case reports to ensure that the data adequately captures the necessary protocol objectives/endpoints.
- Develop and define IIT protocol development and IIT amendment processes to increase efficiently and accuracy leading to reduced study start up timelines, a decrease of on-study deviations, and fewer protocol amendments.
- Review our contractual agreements for our IITs that involve Industry partners to ensure all required elements are being adhered to.
- Providing regulatory oversight for our IITs
- Attend and prepare material concerning protocol management metrics to appropriate stakeholders including HCI Sr. Research Leadership committees.
- Facilitates cooperative and collaborative community and institutional relationships.
- Coordinates with the Clinical Site Monitor and Audit team when needed to address research compliance related matters.
- Facilitates cooperative and collaborative community and institutional relationships
Problem-Solving
This position utilizes federal, institutional guidelines and requirements to inform and complete submission of regulatory documents. This position also negotiates with University research committees and sponsors to ensure full compliance and communication.
https://safety.utah.edu/safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.
The incumbent decides how to best accomplish the daily requirements of various regulatory objectives, prioritizes workload and establishes systems needed to achieve specific goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved following FDA, Good Clinical Practice, IRB, NIH, and/or other regulatory agency guidelines. Incumbent will be responsible for resolving and/or making appropriate recommendations for correction or full resolution to the Director and other members of the management team.
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.
Nearly Continuously: Sitting, hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking.
Seldom: Bending, reaching overhead.
Minimum Qualifications
Bachelor’s degree in a related area or equivalency (one year of education can be substituted for two years of related work experience). Four to six years of progressively more responsible management experience. Background knowledge of hiring department’s area of specialization in order to analyze, plan and draw conclusions for recommendations to superiors. Demonstrated leadership skills in planning and directing employees and processes in order to effectively monitor and develop subordinates and to ensure the smooth operation of department. Master’s degree in a related area may be preferred.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
Preferences
- Three to Five (5 ) years working experience in clinical research
- 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 trial development process.
- 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.
- 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)
383 University Street, Level 1 OEO Suite
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 or call 801-581-2300.
Office of Equal Opportunity and Affirmative Action (OEO/AA)
383 University Street, Level 1 OEO Suite
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 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.
https://safety.utah.edu/safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.
Posting Specific Questions
Required fields are indicated with an asterisk (*).
- * 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
- * Do you have four or more years of progressively more responsible management experience?
- Yes
- No
- Which pronouns do you prefer that people use for you?
- She, her, hers
- He, him, his
- They, them, theirs
- Ze, hir, hirs
- Just my name, please
- Do you have any current relatives working in HCI?
(Open Ended Question)
Applicant Documents
Required DocumentsOptional Documents
- Resume
- Cover Letter
- Appropriate discharge document (such as a DD-214 – Member Copy 4) – Veteran Only – Call 801.581.2169
- Addendum to the University of Utah - Veteran Only - Call 801.581.2169 after submission
Open Date
10/26/2023
Requisition Number
PRN36739B
Job Title
Manager, Clinical Research
Working Title
Research Mgr, Protocol Management
Job Grade
G
FLSA Code
Administrative
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
60700 to 115300
Close Date
Open Until Filled
Yes
Job Summary
JOB TYPE
Full Time
INDUSTRY
Colleges & Universities
SALARY
$107k-137k (estimate)
POST DATE
10/28/2023
EXPIRATION DATE
04/26/2024
WEBSITE
utah.edu
HEADQUARTERS
SALT LAKE CITY, UT
SIZE
15,000 - 50,000
FOUNDED
1850
TYPE
Private
CEO
DAVID W PERSHING
REVENUE
$1B - $3B
INDUSTRY
Colleges & Universities
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