Quality Assurance Coordinator
Job description
The University of Arizona Cancer Center Cancer Prevention Clinical Research Program (UACC CPre) is seeking a highly-motivated individual to coordinate clinical research data and perform quality assurance duties. This individual will work as part of our team coordinating, maintaining, and tracking data submissions and data queries for clinical trials conducted by the UACC CPre and our affiliate organizations per the CPre's oversight requirements as directed by the NCI's Cancer Prevention Clinical Trials Network (CP-CTNet). This position will also support the program through performing clinical research monitoring and quality assurance duties, managing projects, meeting coordination, correspondence, and other duties as needed.
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.
- Clinical research data entry/data monitoring and oversight/query resolution/tracking.
- Apply Good Clinical Practice (GCP)and the Code of Federal Regulations to coordinate the data management requirements of CIRB approved clinical trials protocols as part of the NCI's Cancer Prevention Clinical Trials Network (CP-CTNet).
- Perform oversight of the clinical trial data activities of affiliate organizations (AOs) as required as a CP-CTNet LeadAcademic Organization (LAO).
- Ensure that all study documentation and source data is accurate and up to date.
- Follow clinical trial protocol calendars and meet all requested data time points.
- Follow up on action items and queries in a timely manner as directed by CP-CTNet SOPs.
- Update the clinical trials management system (CTMS) with respect to study status and actions as necessary.
- Educate AO study staff on all aspects of data entry, maintenance, and query resolution as necessary.
Gain access to all associated clinical trial data management systems and confirm all necessary AO staff have access. - Identify and address any study-related issues, including but not limited to inadequate or missing source documentation, adverse event reporting, and protocol deviations or violations.
- Maintain open, effective communication with study staff, PIs, and leadership at UAZ as well as staff at AOs, CP-CTNet, and sponsor-designated data coordinating center.
- Discretion to resolve issues independently.
- Clinical research monitoring and quality assurance.
- Participate in routine and end of study monitoring and auditing processes for assigned studies to ensure compliance with policies, regulations, protocols, and SOPs.
- Working closely with CRCs and Regulatory Coordinator, perform oversight of the clinical trial activities of (AOs) as required as a CP-CTNet LAO.
- Perform quality assurance duties including QA/QC on study materials such as source documents, patient-facing materials, checklists, and regulatory submissions.
- Meeting coordination/administrative duties as assigned.
- Actively participate in assigned program area(s) by preparing agendas and minutes for study team meetings.
- Participate in and help create trainings and attend required staff meetings.
- Perform other administrative duties as necessary to support the CPre clinic team.
- Other duties as assigned.
Knowledge, Skills & Abilities
- Ability to communicate effectively with varying groups/individuals.
- Ability to multitask, organize and prioritize projects.
- Knowledge of clinical trial workflows.
- Ability to adapt to changing priorities.
- Ability to work well both individually and as part of a team.
- Knowledge of clinical trial monitoring and quality assurance.
- Adept with Microsoft Office applications
- Minimum of (3) years of relevant work experience is required.
- Bachelor's degree or equivalent advanced learning attained through professional level experience required.
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