Quality Assurance Assistant, Public Health Institute
The Public Health Institute (PHI) is an independent, nonprofit organization dedicated to promoting health, well-being and quality of life for people throughout California, across the nation and around the world. As one of the largest and most comprehensive public health organizations in the nation, we are at the forefront of research and innovations to improve the efficacy of public health statewide, nationally and internationally. PHI was distinguished as one of the top 50 “Best Non-profit Organizations to Work For” by the Non-Profit Times in a national search.
PHI is seeking an Quality Assurance Assistant for the Children’s Oncology Group. This position is based in Monrovia, CA.
The QA Assistant (QAA) works with the QA Coordinator, Regulatory Project Manager and the Manager of Quality Assurance and Audit to assist in the performance of institutional audits. This individual will also be responsible for organizing the AERS reports and maintaining IRB data for regulatory audits.
Duties & Responsibilities:
- Prepare all audit materials in advance of each institutional audit, including Phase I audits,
- Includes downloading and collating the data forms that have been submitted from member sites to the Operations Center or Data Coordinating centers.
- Populating and re-formatting audit worksheets.
- Downloading necessary forms from CTMB-AIS, and reviewing for completeness.
- Generate pre-SDV workbooks from Medidata RAVE.
- Communicate with Auditors and institutions, as necessary, to set up and follow through with data collection in connection with audits, both prior to the audit and after.
- Provide audit materials specific to each audit to auditors in a timely manner, in line with departmental timelines.
- Coordinate submission of DARFs and roadmaps from sites. Organize submitted DARFs and roadmaps and provide to auditors in advance of the institutional audit.
- Receive, review, file and distribute preliminary audit reports.
- Follow up with auditors for necessary revisions.
- Maintain audit tracking log as it pertains to audit packets, DARFs/roadmaps and preliminary reports.
- Update and maintain IRB submission data for each study on a weekly basis.
- Responsible for electronically filing all documents that come into the Audit department via fax and postal mail.
- Provide back-up to the Audit Coordinator in the department as necessary.
- Perform special projects as requested.
- Monitor the AERS inbox and download and save incoming AERS reports on a daily basis.
- Work with the Regulatory Project Manager and Quality Assurance and Audit Manager to submit AERS reports to the regulatory bodies as required.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- High School Diploma, Associate’s Degree preferred
- A minimum of 4-5 year of administrative experience required
- Experience in clinical research highly desirable, CCRP preferred.
- Must be well organized, detail oriented and have outstanding verbal and written communication skills.
- Must have solid interpersonal skills.
- Must be computer literate, particularly in Microsoft Word and Microsoft Excel.
- Initiative to prioritize work and interact with Group leaders is essential.
This is a non-exempt position and the hourly wage is commensurate with experience. PHI offers a generous benefits package including medical, dental, vision, short/long term disability insurance, life insurance, 403b (group retirement annuity) and partial subsidy of public transportation cost. For more information about PHI’s benefits, visit our benefits page at https://www.phi.org.
How to apply:
To apply for this position visit our Career Site at https://www.phi.jobs.
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