What are the responsibilities and job description for the Compliance Auditor (Research Auditor), DSMC position at Indiana University Bloomington?
Job Summary
The IU Simon Comprehensive Cancer Center (IUSCCC) is seeking a DSMC Compliance Auditor to assist with the implementation and coordination of safety auditing / monitoring as part of the Data and Safety Monitoring Committee (DSMC). This role is a risk management role for the IUSCCC and will ensure adherence to all research standards set forth by the International Council on Harmonization (ICH) Good Clinical Practices (GCP), Food and Drug Administration (FDA), the Human Subjects Office (HSO), Indiana University, National Cancer Institute (NCI) and other pertinent regulatory agencies, and adheres to institutional Standard Operating Procedures.
Department-Specific Responsibilities
- Responsible for Cancer Center-wide monitoring of serious adverse events, reportable events, and deviations.
- Responsible for DSMC meeting planning and management, report generation, documentation of minutes, and pre-review.
- Runs reports from databases, collates the data to identify trends and track progress with team responses, and routinely shares progress with the DSMC.
- Responsible for official communication with study teams on behalf of the DSMC.
- Independently manages schedule to provide support for ongoing DSMC meetings.
- Conducts annual Low Risk DSMC Reviews.
- Monitors or audits a subset of investigator-initiated trials to meet the requirements of the IUSCCC Data and Safety Monitoring Plan.
- Assists with review and approval of Data & Safety Monitoring Plans as part of scientific protocol review.
- Participates in the development, coordination and support of QA and compliance functions and educational activities, including educational presentations, creating guidance documents, and other related responsibilities.
General Responsibilities
Qualifications
Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.
EDUCATION
Required
WORK EXPERIENCE
Required
LICENSES AND CERTIFICATES
Preferred
SKILLS
Required
Working Conditions / Demands
This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment and the campus. The person in this role must be able to perform the essential functions with or without an accommodation.
Work Location
This position is eligible for remote work or to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs.
Benefits Overview
For full-time staff employees, Indiana University offers a wide array of benefits including :
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.
Job Classification
Career Level : Career
FLSA : Exempt
Job Function : Research
Job Family : Research Compliance
Click here to learn more about Indiana University's Job Framework.
Posting Disclaimer
This posting is scheduled to close at 11 : 59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
Equal Employment Opportunity
Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University’s Notice of Non-Discrimination here which includes contact information.
