Research Compliance Administrator III, Department of Internal Medicine (Phoenix)
Posting Number: req21855
Department: COM Phx Internal Medicine
Location: Greater Phoenix Area
Address: 475 N. 5th St, Phoenix, AZ 85004 USA
Position Highlights
The Clinical Research Compliance Team is a functional component of the Internal Medicine centralized clinical trials unit that is organized to provide support for new and ongoing efforts in clinical research at College of Medicine Phoenix. The Compliance Team also provides quality assurance/quality control monitoring of ongoing clinical research and provide training to ensure compliance in research conduct.This Research Compliance Administrator III position will provide dedicated administrative support and training to research investigators and staff to ensure compliance to regulatory requirements for conducting clinical trials. It is expected that this person will have knowledge regarding clinical research practices, monitoring/auditing processes, and regulatory requirements.
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 retirement plan; access to UA recreation and cultural activities; and more!
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Duties & Responsibilities
- Coordinates and conducts monitoring and auditing to ensure compliance with policies, regulations, protocols and SOPs.
- Review and track regulatory documentation.
- Monitors and inspects facilities and research conditions to determine health hazards, and recommends corrective or preventative actions.
- Conduct clinical study monitoring, ensuring compliance with the protocol, Code of Federal Regulations/International Conference of Harmonization/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.
- Develop and/or advise on research compliance procedures, processes, and policies (i.e. SOPs, policies, CAPA plans).
- Provides technical and regulatory advice and training in the areas of research compliance and safety.
- Advises Pl and study team on compliance, safety and regulatory components during proposals/protocol development.
- Prepare, coordinate and maintain regulatory compliance and related documentation required by compliance departments, regulatory agencies or sponsors.
- Assist to prepare and/or coordinate protocol reviews (includes new protocol developments, IND/IDE, IRB, sponsoring agency compliance review and other regulatory agency reviews).
- Works with federal and state officers of administration and staff to ensure uniformity of review and compliance with standard operating procedures and applicable federal and state regulations.
- May review correspondence and conduct quality improvement initiatives.
- Monitor close communication with site staff to assure adherence to protocol and regulatory guidelines and resolve problems timely.
- Maintain thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines.
- Serve as a role expert and as a primary resource for answering role related and compliance process related questions.
- Maintain up to date site research activity date for metrics reporting utilizing internal and institutional databases.
Knowledge, Skills, and Abilities:
- Strong organizational, administrative, communication, and interpersonal skills.
- Proficient computer skills with Internet and MS Office (Outlook, Word, Excel etc.).
Minimum Qualifications
- Bachelor's degree or equivalent advanced learning attained through professional level experience required.
- Five (5) years of relevant work experience, or equivalent combination of education and work experience.
Preferred Qualifications
* Master's degree in a related field of study.
* Research experience.
* Experience working in a Clinical Trial Office at an Academic Center.
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: $59,404 - $74,254
Compensation Type: salary at 1.0 full-time equivalency (FTE)
Grade
8
Compensation Guidance
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 Minimum, Midpoint, and Maximum Fields listed below represent a full range of career compensation growth over time in this position and grade. Each unit typically sets starting pay between minimum and midpoint upon hire. 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.
Grade Range Minimum
$59404
Grade Range Midpoint
$74254
Grade Range Maximum
$89105
Career Stream and Level
PC3
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
Contact Information for Candidates
College of Medicine-Phoenix, Office of Human Resources
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. Blank or missed information may be considered an incomplete submission.
Letter of Interest: Should clearly indicate how your skills and professional employment experience meet the Minimum and the Preferred qualifications (if applicable).
Notice of Availability of the Annual Security and Fire Safety Report
In compliance with the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act (Clery Act), each year the University of Arizona releases an Annual Security Report (ASR) for each of the University's campuses. These reports disclose information including Clery crime statistics for the previous three calendar years and policies, procedures, and programs the University uses to keep students and employees safe, including how to report crimes or other emergencies and resources for crime victims. As a campus with residential housing facilities, the Main Campus ASR also includes a combined Annual Fire Safety report with information on fire statistics and fire safety systems, policies, and procedures.
Paper copies of the Reports can be obtained by contacting the University Compliance Office at cleryact@arizona.edu.
