Regulatory Coordinator

Location
Tucson, AZ
Posted
Nov 14, 2020
Institution Type
Four-Year Institution
Posting Number:

req3164

Department:

Senior VP Health Sciences

Department Website Link:

Location:

UAHS - Tucson

Address:

Tucson, AZ USA

Position Highlights:

The University of Arizona Health Sciences (UAHS) Office of Research Administration is looking for a coordinator for research administration to work closely with colleagues in a fast-paced environment. This position will offer ample opportunity to learn about the world of research administration in support of faculty who conduct research in the multiple colleges that comprise the University of Arizona Health Sciences. The position will work closely with faculty, research nurses, study teams, and our medical partner, Banner Health, to provide timely and expert support in the administrative start-up and maintenance of clinical research projects.

Outstanding UA benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; UA/ASU/NAU tuition reduction for the employee and qualified family members; state and optional retirement plans; access to UA recreation and cultural activities; and more!

The University of Arizona has been recognized for our innovative work‐life programs. For more information about working at the University of Arizona and relocations services, please click here.

As a cost-saving measure related to the impact of COVID-19, Furlough and Furlough-Based Salary Programs have been approved by the Arizona Board of Regents. All new hires subject to the programs will be notified in accordance with adopted Furlough and Furlough-Based Salary Programs guidelines and will be required to comply with all measures. To learn more about the programs and whether this position is affected, please visit hr.arizona.edu/FY-2020-2021-Furlough-Program.

Duties & Responsibilities:

  • Supports faculty, trainees, staff,and others in preparing, finalizing, and submitting timely and complete IRBapplications and authorizations including: new projects, amendments,modifications, deferrals, partial HIPAA waivers, continuing review reports,safety/adverse event or deviation reports, and IND/IDE applications. Communicate time lines and/or impact of approvals to research team operations.
  • Drafts proposal language and protocol guidance regarding human subjectprotections.
  • Stay up-to-date on IRB policies and processes to ensure accurate and timelysubmissions.
  • Obtains and organizes otheressential documents necessary for study approval. Maintains electronicand hard copy regulatory files for assigned studies, including human subjectstraining certificates and financial conflict of interest reporting.
  • Coordinate regulatory activities from study start-up to close-out. Including completion and management of internal and external forms related toclinical trials. Including but not limited to UAccess Research, ResearchIntake Application, FDA Form 1572, Financial Disclosures, Banner Routing,regulatory binder maintenance, etc.
  • Applies for and maintains NIH Certificates of Confidentiality for studies as needed.
  • Update OnCore Clinical TrialManagement System (CTMS) and eRegulatory Management System relating to studystatuses and actions. Provide training and support to UAHS community.
  • Institutional administrator forClinicaltrials.gov.

Minimum Qualifications:

  • Minimum of 3 years of relevant work experience is required.
  • Bachelor's degree or equivalent advanced learning attained through professional level experience required.

Preferred Qualifications:

• Demonstrated knowledge of university and sponsor agency policies and procedures.• Demonstrated ability to work effectively and efficiently in a high-volume work environment.• Demonstrated ability to work in a fast paced, dynamic team environment with changing priorities.• Standout colleague who supports the team and is able to resolve issues with a positive outcome.• Demonstrated ability to work in a manner that is effective and efficient.• Experience with UA systems, specifically UAccess Research. • Willingness to adjust schedule to work weekend and evening hours when necessary.• Demonstrated experience working with IRBs (UA & central)• Valid certificate of CITI training for human subject’s research, or equivalent.• Demonstrated knowledge of the principles and practices of a OnCore Clinical Trial Management System (CTMS) and eRegulatory Management System.• Excellent written and verbal communication skills and significant attention to detail.• Self-motivated, takes initiative, and a strong ability to multi-task multiple projects.• Ability to work effectively in a team environment.• Demonstrated ability to interact professionally and effectively with investigators, sponsors, and cross-functional teams.• Demonstrated customer service.• Excellent computer skills in Microsoft Office.

FLSA:

Exempt

Full Time/Part Time:

Full Time

Number of Hours Worked per Week:

40

Job FTE:

1.0

Work Calendar:

Fiscal

Job Category:

Research

Benefits Eligible:

Yes - Full Benefits

Rate of Pay:

$33,487 - $55,813

Compensation Type:

salary at 1.0 full-time equivalency (FTE)

Grade:

5

Career Stream and Level:

PC2

Job Family:

Research Compl

Job Function:

Research

Type of criminal background check required::

Name-based criminal background check (non-security sensitive)

Number of Vacancies:

1

Target Hire Date:

11/13/2020

Expected End Date:

Contact Information for Candidates:

Chris [email protected] 520-626-1542

Open Date:

11/13/2020

Open Until Filled:

Yes

Documents Needed to Apply:

Resume, Cover Letter, and One Additional Document

Special Instructions to Applicant:

In addition to the resume and cover letter, please provide 3 references.

Diversity Statement:

At the University of Arizona, we value our inclusive climate because we know that diversity in experiences and perspectives is vital to advancing innovation, critical thinking, solving complex problems, and creating an inclusive academic community. As an Hispanic-serving institution, we translate these values into action by seeking individuals who have experience and expertise working with diverse students, colleagues, and constituencies. Because we seek a workforce with a wide range of perspectives and experiences, we provide equal employment opportunities to applicants and employees without regard to race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or genetic information. As an Employer of National Service, we also welcome alumni of AmeriCorps, Peace Corps, and other national service programs and others who will help us advance our Inclusive Excellence initiative aimed at creating a university that values student, staff and faculty engagement in addressing issues of diversity and inclusiveness.

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