The mission of the IU Simon Cancer Center (IUSCC) Clinical Trials Office (CTO) is to support and facilitate the conduct of quality clinical research by IUSCC translational clinical investigators. The CTO is a centralized resource available to all clinical investigators of the IU Simon Cancer Center whose services enable the safe and efficient conduct of adult and pediatric trials. The CTO assists in protocol development, IND / IDE management and coordinates the scientific review of proposed trials by the Protocol Review and Monitoring System (SRC) of the cancer center.
The Clinical Trials Office is currently seeking a Clinical Trials Reporting Program (CTRP) Coordinator. This position reviews, analyzes, registers and maintains all studies and accruals for interventional and non-interventional trials open at IUSCC and its affiliates in compliance with National Cancer Institute (NCI) requirements. Conducts quality assurance checks to identify outliers, missing and/or conflicting data, and addresses and rectifies those discrepancies.
This position ensures IUSCC research is reported to the NCI in accord with requirements set forth by the NCI, Food and Drug Administration (FDA), university, sponsors, Institutional Review Board (IRB), departmental SOPs, and other regulatory bodies. It is focused on quality and compliance across multiple systems, university schools and departments and institutions to ensure accurate and timely reporting of all IUSCC interventional and non-interventional trials conducted on oncology patients for the IUSCC's Cancer Center Support Grant (CCSG). This position is responsible for timely, accurate data reporting within our Clinical Trial Management System (CTMS) for Data Table 4 (DT4) requirements and CCSG renewals. Serves as point of contact for the NCI on behalf of IUSCC. Collaborates with IUSCC Executive Leadership for CCSG write-ups, reports, and future renewals.
Bachelor's degree and two years of experience in clinical research.
Combinations of education and related experience may be considered.
Possess a high attention to detail (both written and verbal) and analytical abilities. Problem solving skills. Ability to take initiative for continuous learning as content changes frequently.
Clinical Research Certification (ARCP or SOCRA). Use of clinical trial management systems. Oncology experience.
Working Conditions / Demands
Must be able to perform the essential functions of the job with or without an accommodation.
Salary Plan: PAE
Salary Grade: 2AD
Job Function: Compliance & Regulatory Affair
This posting is scheduled to close at 11:59pm 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 without regard to 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 .
Campus Safety and Security
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online . You may also request a physical copy by emailing IU Public Safety at firstname.lastname@example.org or by visiting IUPD.
Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.