Skip to Main Content

Manager, Clinical Research

Announcement

Details

Open Date 10/27/2017
Requisition Number PRN15580B
Job Title Manager, Clinical Research
Working Title Manager, Clinical Research
Job Grade G
FLSA Code Administrative
Patient Sensitive Job Code? Yes
Standard Hours per Week 40
Full Time or Part Time? Full Time
Shift Day
Work Schedule Summary

M-F, 9-5

VP Area President
Department 01167 - HCI Clinical Trials Operations
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 60700 to 75000
Close Date<br /><br /><strong>NOTE:</strong> May close at anytime.
Open Until Filled<br /><br /><strong>NOTE:</strong> May close at anytime. No
Job Summary

The Huntsman Cancer Institute Clinical Trials office is hiring a Manager of Clinical Research responsible for direct oversight of disease specific Clinical Research Coordinator (CRC) and Research Data Coordination (RDC) teams. The position will be responsible for management of team functions as a support to Principal Investigators conducting clinical research. Under minimal supervision, the position is responsible for planning, organizing, directing and overseeing all aspects of the team’s daily clinical research functions, administration needs, human resource and financial management operations pertaining to areas including (but not limited to) clinical data, protocol compliance, standardization of processes, monitoring/oversight of clinical trial operations, development and completion of all aspects of clinical studies as it relates to coordination and data completion requirements. Acts as a catalyst between the department and its customers (PIs) and staff to ensure continuity and quality of service and patient care.

Responsibilities

Applicants must demonstrate the potential ability to perform essential job functions.
1. Supports Principal Investigators (PI) and study management staff with patient screening/enrollment, eligibility review, data submission, and overall maintenance of new and ongoing clinical trials. 2. Ensures study management staff are providing quality source documents and data to sponsors, while ensuring protocol compliance is maintained within regulatory guidelines and standards. 3. Routinely monitor and ensure compliance with eligibility, protocol requirements, data submission completion while monitoring delinquency rates, outstanding query resolutions 4. Manage standing team meetings to discuss issues related to the CRC/RDC team and clinical trial needs. 5. Ensure monitoring/auditing reports and outstanding issues with staff are identified, addressed, and resolved in appropriate timeframe while providing direction and oversight. 6. Provides direct personnel management and supervision, while mentoring and training new or junior research staff and providing adequate team coverage plans. 7. Contribute to developing educational materials on coordination and data completion processes and requirements for the teams, as well as evaluation and education tools to assess staff competency. 8. Coordinate with MDG and PIs to provide information on available or competing protocols, workload resourcing for team while providing primary point of contact support for completion of start-up activities (i.e., initiating CDA, Feasibility, MDG scoring and navigation of review committees required for activation, etc.). 9. Prepare clinical research reports for PIs, MDGs, HCI Leadership and sponsors. 10. Participate in CTO Leadership Meetings and ad hoc CTO Working Groups while working closely and collaboratively with fellow CTO Program Managers and Director. 11. Provides transparent clear directives and constructive, professional communication with fellow Program Managers to promote uniformity across MDGs and within the CTO. 12. Actively attend and participate in representation of the Clinical Trials Office at MDG and RIP meetings for primary teams and as needed for other Clinical Program Managers. 13. Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Practice Documents (WPDs) 14. Oversee and ensure completeness in appropriate AE and SAE reporting requirements as well as Deviation reporting to sponsors and the IRB. 15. Facilitate cooperative and collaborative institutional relationships. 16. Ensures PI and MDG satisfaction by analyzing complaints, concerns and suggestions and providing appropriate follow-through. 17. OTHER: Assume responsibility for additional assignments as directed by the CTO Director of Operations.

Problem Solving
The incumbent decides how to best accomplish the daily requirements of various clinical trial requirements, prioritizes and delegates workload and establishes systems needed to achieve specific team and department goals. Efforts of multiple departments or disciplines (i.e., Regulatory, Finance, and Specimen Processing) must be coordinated to ensure effective follow through and compliance of all involved.
The incumbent is expected to closely monitor studies in which experimental equipment and drugs are utilized. Federal regulations mandate the regulatory requirements for use of investigational new drugs or devices and the subjects participating in research studies often have no other option for recovery. Analysis on critical research studies is required in order to maintain accurate patient and data compliance with all aspect of the research study in accordance with federal regulations.
The incumbent utilizes federal and institutional guidelines and requirements to ensure compliant execution of clinical trial activities. This position negotiates and communicates extensively with other Clinical Trials Office Managers and the University human subject research protection committees and sponsors to ensure full compliance.
The incumbent is responsible to organize coverage when not present to ensure clinical trial requirements are followed.

Minimum Qualifications

Bachelor’s degree in a related area or equivalency (2 years related work experience may be substituted for 1 year of education). 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.

Preferences

Requires a Bachelor’s degree in a related area of assignment or equivalency and 4 – 6 years of progressively more responsible management experience. 5 years of clinical research experience is required.
Background knowledge of assigned department’s area of specialization in order to analyze, plan, train and draw conclusions for recommendations to Clinical Trial Directors. 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.
Completion of provided supervisory/management 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.

Successful candidates will have: • Progressive leadership experience preferably in the clinical research industry • Advanced knowledge and understanding of regulatory guidelines related to human subject research protections in clinical trial investigations • Clinical Trial Management Software experience (i.e., OnCore, Velos) • Ability to assess functional processes, workflow and develop improvements for efficiency and quality output. • Advanced knowledge of industry standards related to clinical trial coordinator functions and study data management activities; (i.e., complex trial designs, data standards, data reviews, etc.). • Demonstrated ability to positively influence others in a team environment • Proactive and critical evaluation of multiple aspects of clinical trial execution to ensure timely completion and quality.

Type Benefited Staff
Special Instructions Summary
Additional Information


The University of Utah is an Affirmative Action/Equal Opportunity employer and is committed to diversity in its workforce. In compliance with applicable federal and state laws, University of Utah policy of equal employment opportunity prohibits discrimination on the basis of race or ethnicity, religion, color, national origin, sex, age, sexual orientation, gender identity/expression, veteran’s status, status as a qualified person with a disability, or genetic information. Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities, and protected veterans are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law.
To inquire about this posting, email: employment@utah.edu or call 801-581-2300. Reasonable accommodations in the application process will be provided to qualified individuals with disabilities. To request an accommodation or for further information about University AA/EO policies, please contact the Office of Equal Opportunity and Affirmative Action, 201 S. Presidents Cr., Rm 135, (801) 581-8365 (V/TDD), email: oeo@umail.utah.edu.


The University is a participating employer with Utah Retirement Systems (“URS”). To be eligible for retirement contributions, you must be hired into a benefit-eligible position. Certain new hires are automatically assigned to the URS retirement plan and other employees with prior URS service, may elect to enroll in the URS within 30 days of hire. Regardless of whether they are hired into a benefit-eligible position or not, individuals who previously retired and are receiving monthly retirement benefits from URS must notify the Benefits Department upon hire. Please contact Utah Retirement Systems at (801)366-7770 or (800)695-4877 or the University’s Benefits Department at (801)581-7447 for information.


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

Posting Specific Questions

Required fields are indicated with an asterisk (*).

  1. * 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
  2. * Do you have four or more years of progressively more responsible management experience?
    • Yes
    • No
  3. Do you have any current relatives working at HCI?

    (Open Ended Question)

Applicant Documents

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter
  2. Appropriate discharge document (such as a DD-214 – Member Copy 4) – Veteran Only – Call 801.581.2169
  3. Addendum to the University of Utah - Veteran Only - Call 801.581.2169 after submission