Act to ensure adherence to regulatory requirements, best practices, and ethical standards in the conduct of research in accordance with Standard Operating Procedures (SOP) and Good Clinical Practice (GCP). Compose and prepare regulatory documents, including initial submission of new studies to IRB, timely completion of continuing reviews, study amendments, updates to Informed Consent forms, process external safety reports, key personnel updates and protocol training.
Primary Responsibilities Include:
Complete initial protocol submissions to IRB and other internal and external regulatory boards. Utilize KC-IRB to create, complete and maintain all IRB required documentation to include questionnaires, consents (study and HIPAA), Investigators Brochure, advertising, protocol and other documents as needed. Complete and submit amendments, continuing reviews, safety reports, prompt reporting key personnel updates and close out forms per IU IRB Standard Operating Procedures. Keep Investigators and clinical research staff updated on status of IRB submission, review, approval, and regulatory documents. Prepare reports to other agencies as necessary.
Maintain regulatory binders for research protocols. Monitor the status of all research studies and follow-up on any required regulatory documentation for ongoing protocols. Maintain database for the efficient storage and retrieval of essential information about each protocol. Work closely with faculty, research staff and research sponsors to update records of ongoing studies. Monitor and maintain current faculty/staff essential regulatory records for CITI Human Subjects training, CITIGCP training, medical licenses, CVs, laboratory certificates, and normal ranges.
Maintain and assist new staff with National Cancer Institute memberships and renewals. Coordinate and assist staff with maintaining the NCI renewals yearly.
Perform other duties as assigned by manager. This could include but is not limited to aiding other research team members with projects related to data collection and/or specific study procedures.
REQUIRED: Bachelors Degree from an accredited institution, plus 2 years related office and administrative experience.
Combinations of related education and experience may be considered.
Knowledge, skills, and abilities: High attention to detail, good communication skills, ability to concentrate with distractions, problem-solving, managing several projects at once, working with deadlines, requires continuous learning as content changes frequently, analytical abilities, personal initiative, use spell and grammar check, double check work prior to submission. Proficient in Microsoft Word and Excel. Maintain current knowledge of regulatory affairs and issues by frequently visiting the ORA website and keeping abreast of changes. Willing to participate in continuing education sessions and project team meetings. Help to develop the structure needed via Regulatory Binders and tracking forms to be in compliance with IU SOPs. Ability to work well with a wide range of staff and faculty from different divisions within Pediatrics. Excellent interpersonal skills. Excellent organizational skills, and ability to prioritize workload and conflicting demands. Work well under the pressure of deadlines.
A comprehensive understanding of research requirements, policies and federal regulations.
Working Conditions/Physical Demands:
Mobility throughout hospital and campus to obtain or relay information; moving of charts and records; remaining in a stationary position for extended periods of time.
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.