Regulatory Coordinator II, Cancer Center (Full-Time

Regulatory Coordinator II, Cancer Center (Full-Time)

Department:
Cancer Center Division.

Location:

Tucson Campus, 1515 N Campbell Ave, Tucson, AZ 85724 USA

This Regulatory Coordinator position will provide dedicated clinical trials administration support for ongoing and new developmental efforts in cancer clinical trials research. This position works closely with clinical faculty and their disease team. This selected candidate will have regular contact with the University of Arizona Human Subjects Protection Program (IRB), investigators, clinical research staff (nurses, data managers), clinical trials sponsors (e.g. private industry and national cooperative groups), and administrative staff.

It is expected that this person will have or develop a knowledge base of the disease areas assigned and current management principles and will be able to serve in a consulting role to new faculty and staff regarding policies and procedures for clinical research.

Visa sponsorship is not available for this positions.

Outstanding U of A benefits include:

• health, dental, and vision insurance plans
• life insurance and disability programs
• paid vacation, sick leave, and holidays
• U of A/ASU/NAU tuition reduction for the employee and qualified family members
• retirement plans
• access to U of A 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 .

Full Time, 40 hours per week, 1.0 FTE. Work Calendar:
Fiscal. Job Category:
Research. FLSA:
Exempt. Benefits Eligible:
Yes - Full Benefits.

Rate of Pay: $53,039 - $66,299 (salary at 1.0 full-time equivalency (FTE)). Grade: 7.

The Rate of Pay Field represents the University of Arizona's good faith and reasonable estimate of the range of possible compensation at the time of posting. The University considers several factors when extending an offer, including but not limited to, the role and associated responsibilities, a candidate's work experience, education/training, key skills, and internal equity.

The Grade Range represent a full range of career compensation growth over time. The university offers compensation growth opportunities within its career architecture. To learn more about compensation, please review our Applicant Compensation Guide and our Total Rewards Calculator.

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

• Prepare and/or coordinate IRB and other required submissions and approvals of new phase I-III and other protocols for industry, investigator-initiated, and national cooperative group studies in assigned program area(s).
• Prepare and/or coordinate IRB and other required submissions of protocol amendments and other revisions, IND safety reports, and progress reports for approval for assigned studies.
• Coordinate other regulatory activities pertaining to clinical trial start-up.
• Conduct compliance reviews, end-of-study monitoring, and audit activities for assigned studies to verify adherence to institutional policies, federal regulations, and study-specific protocols and SOPs.
• Support new employees by demonstrating proper work practices, adhering to established institutional process & policy.
• Prepare, coordinate, and maintain regulatory compliance and related documentation required by regulatory agencies and sponsors.
• Update the clinical trials management system (CTMS) with respect to study status and actions.
• Provide regulatory advice and training on routine items to colleagues in assigned program area(s).
• Actively participate in assigned program area(s) by scheduling and preparing agendas and minutes for program area meetings.
• On an as-needed basis, review routine submissions and other assignments for quality assurance.
• Participate in the development and implementation of procedures and processes within the regulatory office.
• Assist in drafting and editing regulatory instructional materials.
• Other duties as assigned.

• Excellent technical writing skills.
• Demonstrated strong…