Regulatory Coordinator II, Cancer Center (Full-Time)

The University of Arizona•Tucson, AZ

1d•Onsite

About The Position

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.

Requirements

Excellent technical writing skills.
Demonstrated strong interpersonal, communication, and problem-solving skills.
Excellent organizational skills.
Knowledge of MS Word (word processing) and Excel.
Knowledge of medical oncology terminology and treatment concepts.
Familiarity with University of Arizona and Federal policies and procedures for protection of human subjects.
Bachelor's degree or equivalent advanced learning attained through professional level experience required.
Minimum of 3 years of relevant work experience, or equivalent combination of education and work experience.

Nice To Haves

Previous experience with national cooperative group and private industry cancer clinical research.

Responsibilities

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.