Indiana University
Assistant Director (Research Compliance Leader)
Indiana University, New Albany, Indiana, United States, 47150
Overview
Assistant Director (Research Compliance Leader) at Indiana University. The Indiana University Human Research Protection Program (HRPP), within the Office for Research Compliance, ensures that human subject research conducted at IU campuses and affiliated hospitals is carried out in an ethically compliant manner. The University supports the day-to-day operations of the Institutional Review Boards (IRBs) through the IU Human Subjects Office (HSO). HSO staff may conduct preliminary reviews, provide guidance on whether an activity requires IRB review, and consult with IRB members as needed. The Quality Improvement Office conducts not-for-cause and for-cause audits of human subjects research. HRPP staff are available to answer questions and offer educational and training opportunities related to human subjects research. Responsibilities
Provides day-to-day operational management of research compliance staff and leadership for associated research compliance activities. Establishes short-term operational objectives. Develops program concepts, objectives, and deliverables; formulates program guidelines, criteria, and policies/procedures; establishes metrics to measure productivity and to recognize areas of concern; develops SOPs for work flow processes according to regulatory guidelines. Identifies operational issues and/or areas of improvement and implements solutions to improve processes and/or operational efficiency. Analyzes, monitors, and evaluates performance of assigned staff; establishes work priorities, conducts performance reviews, and provides corrective action as needed. Ensures adequate staffing and effective scheduling; participates in and informs employment decisions for assigned staff. Provides direct supervision and oversight of assigned staff and activities; responsible for the performance of the team and/or assigned staff. Ensures and provides training to assigned staff to improve research compliance protocols; researches and identifies development opportunities for assigned staff. Keeps next-level leader(s) informed of trends and significant problems. Qualifications
Bachelor's degree (preferably in related field) 5 years experience consulting and advising on research compliance Experience with IRB convened board meeting procedures Certified IRB Professional (CIP) upon date of hire Proficient communication skills Maintains a high degree of professionalism Demonstrates time management and priority setting skills Demonstrates a high commitment to quality Excellent organizational skills Excellent collaboration and team building skills Effectively coaches and delivers constructive feedback Instills commitment to organizational goals Knowledge of applicable laws, regulations, and policies pertaining to compliance programs Additional requirements
This role requires the ability to effectively communicate and 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. Location: Indianapolis, Indiana. This position is eligible for remote work or a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs. Benefits and employment type
For full-time staff, Indiana University offers a wide array of benefits including: Comprehensive medical and dental insurance Health savings account with generous IU contributions Healthcare and dependent care flexible spending accounts Basic group life insurance paid by IU Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance Base retirement plan with generous IU contributions, subject to vesting Voluntary supplemental retirement plan options Tuition subsidy for employees and family members taking IU courses 10 paid holidays plus a paid winter break each year Generous paid time off plans Paid leave for new parents and IU-sponsored volunteer events Employee assistance program (EAP) Job Function: Research; Job Family: Research Compliance; Career Level: Operational; FLSA: Exempt. This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. It may be closed at any time at the University’s discretion 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. Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination for details. Other
Application tips: If you wish to include a cover letter, you may attach it with your resume during upload. The Annual Security and Fire Safety Report is available online or by request via IU Public Safety. This posting is provided for informational purposes; no change to status is implied by this description.
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Assistant Director (Research Compliance Leader) at Indiana University. The Indiana University Human Research Protection Program (HRPP), within the Office for Research Compliance, ensures that human subject research conducted at IU campuses and affiliated hospitals is carried out in an ethically compliant manner. The University supports the day-to-day operations of the Institutional Review Boards (IRBs) through the IU Human Subjects Office (HSO). HSO staff may conduct preliminary reviews, provide guidance on whether an activity requires IRB review, and consult with IRB members as needed. The Quality Improvement Office conducts not-for-cause and for-cause audits of human subjects research. HRPP staff are available to answer questions and offer educational and training opportunities related to human subjects research. Responsibilities
Provides day-to-day operational management of research compliance staff and leadership for associated research compliance activities. Establishes short-term operational objectives. Develops program concepts, objectives, and deliverables; formulates program guidelines, criteria, and policies/procedures; establishes metrics to measure productivity and to recognize areas of concern; develops SOPs for work flow processes according to regulatory guidelines. Identifies operational issues and/or areas of improvement and implements solutions to improve processes and/or operational efficiency. Analyzes, monitors, and evaluates performance of assigned staff; establishes work priorities, conducts performance reviews, and provides corrective action as needed. Ensures adequate staffing and effective scheduling; participates in and informs employment decisions for assigned staff. Provides direct supervision and oversight of assigned staff and activities; responsible for the performance of the team and/or assigned staff. Ensures and provides training to assigned staff to improve research compliance protocols; researches and identifies development opportunities for assigned staff. Keeps next-level leader(s) informed of trends and significant problems. Qualifications
Bachelor's degree (preferably in related field) 5 years experience consulting and advising on research compliance Experience with IRB convened board meeting procedures Certified IRB Professional (CIP) upon date of hire Proficient communication skills Maintains a high degree of professionalism Demonstrates time management and priority setting skills Demonstrates a high commitment to quality Excellent organizational skills Excellent collaboration and team building skills Effectively coaches and delivers constructive feedback Instills commitment to organizational goals Knowledge of applicable laws, regulations, and policies pertaining to compliance programs Additional requirements
This role requires the ability to effectively communicate and 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. Location: Indianapolis, Indiana. This position is eligible for remote work or a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs. Benefits and employment type
For full-time staff, Indiana University offers a wide array of benefits including: Comprehensive medical and dental insurance Health savings account with generous IU contributions Healthcare and dependent care flexible spending accounts Basic group life insurance paid by IU Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance Base retirement plan with generous IU contributions, subject to vesting Voluntary supplemental retirement plan options Tuition subsidy for employees and family members taking IU courses 10 paid holidays plus a paid winter break each year Generous paid time off plans Paid leave for new parents and IU-sponsored volunteer events Employee assistance program (EAP) Job Function: Research; Job Family: Research Compliance; Career Level: Operational; FLSA: Exempt. This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. It may be closed at any time at the University’s discretion 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. Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination for details. Other
Application tips: If you wish to include a cover letter, you may attach it with your resume during upload. The Annual Security and Fire Safety Report is available online or by request via IU Public Safety. This posting is provided for informational purposes; no change to status is implied by this description.
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