Job Information

University of Utah Project Administrator (Mentor & Training Manager) in Salt Lake City, Utah

Open Date 10/07/2021

Requisition Number PRN27937B

Job Title PS Project Administrator

Working Title Project Administrator (Mentor & Training Manager)

Job Grade F

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

VP Area President

Department 01167 - HCI Clinical Trials Operations

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 47600 to 65000

Close Date

Open Until Filled Yes

Job Summary

The Huntsman Cancer Institute Clinical Trials Office ( CTO ) is hiring a Project Administrator responsible for mentorship and training oversight of Clinical Research Coordinator ( CRC ) and Research Data Coordinators ( RDC ) positions. The position will be responsible for management of all training materials for onboarding new employees and serving as a mentor for these roles as they support clinical research functions. Mentoring and training roles to navigate the complex arena of human subject clinical trials will be the primary function. Mentorship related to interactions with Principal Investigators, providers, patients, clinics, sponsors and other departments within the CTO and Research Compliance Office ( RCO ) are necessary. Under minimal supervision, the position is responsible for planning, organizing, directing and overseeing all aspects of the Canvas system utilized for the CTO Training Program. Trainings related to CTO 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 employee and the Clinical Research Operations Managers as well as the Clinical Investigators (PIs and SubIs) and to ensure continuity and quality of service and patient care.

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

Applicants must demonstrate the potential ability to perform essential job functions.

  1. Oversee the training program and mentorship of all new Clinical Research Coordination ( CRC ) and Research Data Coordination ( RDC ) staff. Conduct ongoing in service trainings for existing Clinical Trials Office ( CTO ) staff, clinical nurses and faculty.
  2. Work on ongoing continuing education opportunities. Conduct training in conjunction with Good Clinical Practice ( GCP ) and regulations.
  3. Develop and oversee Canvas Training System for the CTO , including general and role specific trainings, oversight of ongoing training requirements and intervals for training certifications (i.e., GCP ).
  4. Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Practice Documents (WPDs).
  5. 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.
  6. Provide clinical trial coordination functions as primary or secondary CRC where needed in CTO .
  7. Ensure staff are providing quality source documents and data to sponsors, while ensuring protocol compliance is maintained within regulatory guidelines and standards.
  8. Participate in CTO Leadership Meetings and ad hoc CTO Working Groups while working closely and collaboratively with fellow CTO Program Managers and Director.
  9. Provides transparent clear directives and constructive, professional communication with fellow Program Managers to promote uniformity across multi-disciplinary disease groups ( MDG ) and within the CTO .
  10. Oversee and ensure completeness in appropriate Adverse Event (AE) and Serious Adverse Event ( SAE ) reporting requirements.
  11. Oversee and ensure completeness in appropriate deviation reporting to sponsors and the IRB . Ensure completeness and oversight of reports via OnCore.
  12. OTHER : Assume responsibility for additional assignments as directed by the CTO Associate Director.

This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Problem Solving

Incumbent is responsible for training of new clinical trials and research compliance office staff on University policies, CTO procedures and required data or research coordination functions in support of clinical research. This position is the primary contact for training of office staff, in service training with clinical personnel and faculty conducting research. The incumbent must possess the ability to foster collaborative working relationships with a wide range of constituencies.

Minimum Qualifications

Bachelor’s degree in Business Administration, Accounting, or a related field, or equivalency; four years of progressively more responsible related experience; and demonstrated human relation and effective communications skills required. A related Master’s degree preferred.

This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers, and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Preferences

Requires a Bachelor’s Degree in a related area of assignment or equivalency and 4 to 6 years of progressively more responsible management experience. Five years of clinical research experience is highly preferred.

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 training and mentoring employees.

Successful candidates will have:

· Certified Clinical Research Professional ( CCRP , CCRC or CCRA )

· Prior experience or knowledge of oncology, and oncology related research

· Prior experience with Institutional Review Board ( IRB ) procedures

· Strong written and oral communication skills

· An understanding of University operations, policies and technology is preferred. Training or teaching experience is also preferred.

· Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

· Progressive leadership experience preferably in the clinical research industry

· Advanced knowledge and understanding of regulatory guidelines related to human subject research protections

· 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

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.