University of Utah Multi-site Project Administrator in Salt Lake City, Utah
Open Date 10/08/2020
Requisition Number PRN24500B
Job Title PS Project Administrator
Working Title Multi-site Project Administrator
Job Grade F
FLSA Code Administrative
Patient Sensitive Job Code? Yes
Standard Hours per Week 40
Full Time or Part Time? Full Time
Work Schedule Summary
VP Area President
Department 01345 - HCI Clinical Resrch Compliance
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 47600 to 64000
Open Until Filled Yes
This position will provide project management, regulatory and data management oversight and clinical monitoring support for multi-site trials coordinated by the Research Compliance Office from trial start-up through trial closeout. The incumbent will act as a liaison between the clinical sites, the Research Compliance Office and sponsors/agencies/cooperative groups to ensure that clinical trials are conducted in compliance with the protocol, and applicable institutional and regulatory guidelines. As a member in the Research Compliance Office 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 position is considered Category IIA : Not required on campus and has the ability to telework remotely for the duration of the University of Utah’s response to COVID -19. An employee hired into this role will be responsible for providing space, telephone, printing, networking and/or internet capabilities at the telecommute location and agree to the terms of the University of Utah campus and Health Academics COVID -19 Telecommuting Agreement.
1.Develop and maintain site feasibility packets, multi-site study procedural manuals, and other multi-site process documents.
2.Prepare clinical sites for study start-up by reviewing and tracking regulatory documents, ordering start-up supplies and conducting site initiation visits.
3.Ensures updated copies of regulatory essential documents are maintained in trial master files and manages the study progress in relation to the project timelines.
4.Assure that the clinical sites are enrolling subjects, collecting data, and conducting the trial in compliance with approved protocol version, GCP and ICH guidelines.
5.Perform dual review of eligibility to verify that potential clinical trial participants meet protocol specific eligibility criteria and provided informed consent according to federal and IRB regulatory guidelines.
6.Performs on-site and remote monitoring activities of clinical research studies, as needed.
7.Monitor adverse events for seriousness and facilitate the AE/ SAE reporting process to ensure that all adverse events are reported to the study supporter and all participating site IRB’s.
8.Communicate with external sites determinations made on behalf of the DSMC .
9.Oversees the maintenance and organization of project documentation and records.
10.Act as a liaison between the clinical site(s), HCI University parties (PI, regulatory team, study team, etc.) study sponsors and/or regulatory agencies and the research compliance office to resolve any issues that may arise throughout the course of the study.
11.Other responsibilities may include but are not limited to; updating and revision of SOPs, training and orientation of study staff, organization of coordinator/investigator meetings.
12.Provides guidance and training to research faculty and staff pertaining to complex and highly specialized rules and regulations including complex protocol, multi-site trials and IND / IDE issues.
13.Assist in the development and submission of investigator initiated clinical studies to appropriate regulatory review committees.
14.Ensures participating sites provide the necessary regulatory documentation to participate in a multi-site investigator initiated trial.
15.Assists in the development of policies, procedures and process improvements for departmental implementation and guidance for external associates.
16.Perform other duties as assigned by management.
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.
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.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
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.
•Experience in the management of clinical trials and the investigator initiated clinical development process.
•Oncology clinical trial experience highly preferred.
•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 development process sufficient to effectively direct and manage multiple projects and timelines.
•Strong attention to detail, establishing priorities, and adhering to deadlines.
•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, Project, and other project management tools.
• SOCRA or ACRP certification.
Type Benefited Staff
Special Instructions Summary
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: firstname.lastname@example.org 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: email@example.com .
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.
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.