Job Listings

Manager, Clinical Research Compliance - Cancer Center

Company:
The University of Arizona
Job Location:
Tucson, Arizona
Category:
Laboratory and Research

Posting Number: req7739

Department: Cancer Center Division

Location: UAHS - Tucson

Address: University of Arizona Cancer Center, 1515 N Campbell Avenue, Tucson, AZ 85724 USA

Position Highlights

The Clinical Research Compliance Manager will provide managerial oversight for the clinical research compliance team staff within the Clinical Research Branch of the University of Arizona Cancer Center (UACC). The position will be a working manager position with protected time for conducting management responsibilities. The UACC Clinical Research Compliance Team (formerly: Quality Assurance/Quality Control (QA/QC)) Team is a functional component of the UACC centralized clinical trials unit that is organized to provide internal quality assurance/quality control and monitoring for investigator-initiated trials that require oversight by the Data and Safety Monitoring Board (DSMB), within the UACC. This position is responsible for the training and mentoring of assigned CTO staff and the efficient and effective management activities of monitoring and auditing the clinical trial portfolio assigned ensuring that all activities are documented with the goal of promoting compliance with appropriate regulations and contractual obligations.

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.

Employee COVID-19 Vaccine Requirement

All University employees are required to submit documentation demonstrating they are fully vaccinated for COVID-19 as a condition of employment unless granted a religious or disability/medical accommodation. New hires must submit their COVID-19 vaccine documentation or accommodation request no later than one week after their hire date or by December 8, 2021, whichever occurs later. To learn more about the employee COVID-19 vaccine requirement, submitting vaccine documentation, and/or requesting an accommodation, please visit https://hr.arizona.edu/content/employee-covid-19-vaccine-requirement.

Duties & Responsibilities

  • Supervise performance of the compliance team and clinical research assigned trials within the Clinical Trials Office (CTO).
  • Supervise the day-to-day activities of the assigned CTO Clinical Research monitors within the clinical research compliance office the University of Arizona Cancer Center (UACC); including prioritization and assignment of work; communication of expectations and standards; hiring, training and ongoing assessment of outcomes; writing and communication of performance evaluations; coaching and disciplinary action activities.
  • Help oversee the initial, and continual, training of staff regarding research industry standards, current CTO policy, and UACC operations.
  • Help the development and maintenance of compliance team procedures regarding trial management to be in harmony with policies set forth by the CTO leadership which are also compliant with applicable federal, state, local and University of Arizona regulations, laws, guidance and policies.
  • Participate in the training and mentoring of staff. This includes training new staff and holding training sessions to keep all staff informed of processes and procedures.
  • Prepare and/or modify monitoring documents.
  • Maintain thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines.
  • Conduct clinical site IIT monitoring, ensuring compliance with the protocol, Code of Federal Regulations/International Conference of Harmonisation/Good Clinical Practices (CFR/ICH/GCP) guidelines, local regulations and applicable Standard Operating Procedures (SOPs).
  • Review source documents and case report forms for clarity, consistency and accuracy.
  • Review and track regulatory and pharmacy documentation; track subject screening and enrollment.
  • Actively participate in CTO management meetings, and the Data and Safety Monitoring Board.
  • Assist in the development and maintenance of CTO support staff professional development.
  • Communicate with site staff to assure adherence to protocol and regulatory guidelines and resolve problems timely.
  • Conduct routine internal monitoring of NCTN cooperative group trials
  • Actively participate in compliance team meetings.
  • Attend and participate in site initiation visits for investigator initiated trials (IITs)
  • Review data and safety monitoring plans for all trials undergoing UACC Scientific Review Committee review.
  • Provide support to CTO staff preparing for external audits, as needed.

Minimum Qualifications

  • Minimum of 3 years of related work experience or equivalent combination of education and work experience required.
  • Bachelor's degree.

Preferred Qualifications

* Current certification as a clinical research coordinator (CCRP, CRC, CRA) or other applicable clinical research certification.
* Previous experience with cancer clinical research.
* Knowledge of the principles and practices of a clinical trial management system (e.g. OnCore).
* Demonstrated ability to interact professionally and effectively with investigators, sponsors and cross-functional teams.
* Working knowledge of university policies and procedures related to research administration.
* Project management experience.

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: $53,946 - $75,896

Compensation Type: salary at 1.0 full-time equivalency (FTE)

Grade

9

Career Stream and Level

M1

Job Family

Clinical Research

Job Function

Research

Type of criminal background check required: Name-based criminal background check (non-security sensitive)

Number of Vacancies: 1

Contact Information for Candidates

Liz McPeak | emcpeak@uacc.arizona.edu

Open Until Filled: Yes

Documents Needed to Apply: Resume and Cover Letter

Special Instructions to Applicant

Application: The online application should be completed in its entirety.

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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