Regulatory Coordinator I, Cancer Center (Full Time)
UNIVERSITY OF ARIZONA, Tucson, AZ, United States
Regulatory Coordinator I, Cancer Center (Full Time)
Posting Number
req25803
Department
Cancer Center Division
Location
Tucson Campus, 1515 N Campbell Ave, Tucson, AZ 85724, USA
Provide dedicated clinical trials administration support for ongoing and new developmental efforts in cancer clinical trials research. Works closely with clinical faculty and their disease team. Regular contact with the University of Arizona Human Subjects Protection Program (IRB), investigators, clinical research staff, sponsors, and administrative staff. Expected to develop a knowledge base of assigned disease areas and current management principles and provide consulting to new faculty and staff regarding clinical research policies and procedures.
Duties & Responsibilities
Prepare and coordinate IRB and other required submissions and approvals of new phase I‑III protocols and other studies in assigned program areas.
Prepare and coordinate IRB submissions of protocol amendments, IND safety reports, and progress reports for approval for assigned studies.
Coordinate regulatory activities pertaining to clinical trial start‑up and conduct.
Participate in routine and end‑of‑study monitoring and auditing processes to ensure compliance with policies, regulations, protocols, and SOPs.
Prepare, coordinate, and maintain regulatory compliance and related documentation required by regulatory agencies and sponsors.
Update the clinical trials management system (CTMS) with study status and actions.
Actively participate in assigned program areas by scheduling and preparing agendas and minutes.
Other duties as assigned.
Knowledge, Skills, and Abilities
Excellent technical writing skills.
Strong interpersonal, communication, and problem‑solving skills.
Excellent organizational skills.
Proficiency with MS Word and Excel.
Knowledge of medical oncology terminology and treatment concepts.
Minimum Qualifications
Bachelor's degree or equivalent advanced learning attained through experience.
At least one year of relevant work experience.
Preferred Qualifications
Familiarity with University of Arizona and Federal policies and procedures for protection of human subjects.
Previous experience with national cooperative groups and private industry cancer clinical research.
Benefits
Health, dental, vision insurance; life insurance and disability programs; paid vacation, sick leave, and holidays; tuition reduction for employee and qualified family members; retirement plans; access to recreation and cultural activities.
Salary and Compensation
Rate of pay: $47,356-$59,195 per year. Full‑time equivalency 1.0 FTE.
Contact for Applicants
Brianna Denton, briannadenton@arizona.edu
#J-18808-Ljbffr
Posting Number
req25803
Department
Cancer Center Division
Location
Tucson Campus, 1515 N Campbell Ave, Tucson, AZ 85724, USA
Provide dedicated clinical trials administration support for ongoing and new developmental efforts in cancer clinical trials research. Works closely with clinical faculty and their disease team. Regular contact with the University of Arizona Human Subjects Protection Program (IRB), investigators, clinical research staff, sponsors, and administrative staff. Expected to develop a knowledge base of assigned disease areas and current management principles and provide consulting to new faculty and staff regarding clinical research policies and procedures.
Duties & Responsibilities
Prepare and coordinate IRB and other required submissions and approvals of new phase I‑III protocols and other studies in assigned program areas.
Prepare and coordinate IRB submissions of protocol amendments, IND safety reports, and progress reports for approval for assigned studies.
Coordinate regulatory activities pertaining to clinical trial start‑up and conduct.
Participate in routine and end‑of‑study monitoring and auditing processes to ensure compliance with policies, regulations, protocols, and SOPs.
Prepare, coordinate, and maintain regulatory compliance and related documentation required by regulatory agencies and sponsors.
Update the clinical trials management system (CTMS) with study status and actions.
Actively participate in assigned program areas by scheduling and preparing agendas and minutes.
Other duties as assigned.
Knowledge, Skills, and Abilities
Excellent technical writing skills.
Strong interpersonal, communication, and problem‑solving skills.
Excellent organizational skills.
Proficiency with MS Word and Excel.
Knowledge of medical oncology terminology and treatment concepts.
Minimum Qualifications
Bachelor's degree or equivalent advanced learning attained through experience.
At least one year of relevant work experience.
Preferred Qualifications
Familiarity with University of Arizona and Federal policies and procedures for protection of human subjects.
Previous experience with national cooperative groups and private industry cancer clinical research.
Benefits
Health, dental, vision insurance; life insurance and disability programs; paid vacation, sick leave, and holidays; tuition reduction for employee and qualified family members; retirement plans; access to recreation and cultural activities.
Salary and Compensation
Rate of pay: $47,356-$59,195 per year. Full‑time equivalency 1.0 FTE.
Contact for Applicants
Brianna Denton, briannadenton@arizona.edu
#J-18808-Ljbffr