Research Compliance Leader
Indiana University

Indianapolis, Indiana

Posted in Education and Training


This job has expired.

Job Info


Department

CLINICAL TRIALS OFFICE (UA-CLTO-IUINA)

Department Information

Indiana University School of Medicine is a committed leader in physician education, medical research and clinical care. Through the successful pursuit of funding, collaborations and talent, the school's achievements across medical specialties are recognized nationally; yet IU School of Medicine is making extraordinary advancements in specific areas of expertise.

Strong partnerships with Indiana hospitals and global biomedical companies enable IU School of Medicine to generate research and implement discoveries in ways that truly benefit individual patient outcomes and overall population health. Collaboration with other universities and schools within Indiana University through federally funded research centers and institutes led by IU School of Medicine faculty is quickening the path from laboratory to treatment.

These critical areas of medicine are particular areas of focus and strength at IU School of Medicine.

Job Summary

The person in this role will serve as the Statewide Research Compliance Leader for Indiana University Office of Clinical Research & IU Health Enterprise Clinical Research Operations.

Department-Specific Responsibilities

  • Advises and consults with faculty, investigators, and review committees and departments (such as IRB) on the submission, review, and approval of research applications and protocols. Submits new initial protocol reviews and reliance agreement requests on the behalf of the statewide research network, supported investigators, and student researchers under the covered workforce, including submissions to additional boards as required (e.g: Office of Research Imaging, Institutional Biosafety Committee, Scientific Review Committee, OCR Coverage Analysis, OnCore Registration, Radiation Safety, IU IRB/central IRBs, etc.). This includes Expanded Access Programs (EAPs/Compassion Use), Humanitarian Use Devices (HUDs) drug, device, investigator-initiated, quality improvement research, and non-human subject protocols.
  • Provides an experienced level of subject matter expertise to faculty and investigators involved in research. Serves as a mentor, advisor, educator, and resource to research compliance staff, research coordinators, students under the covered workforce, and medical support teams across the statewide network for both IU and IU Health staff. Ensures all research personnel, both affiliated and unaffiliated with IU/IU Health (eg: Purdue employees, contract employees, CROs, and students from external universities) to ensure full compliance with institutional requirements for both IU and IU Health (HIPAA compliance, Data Safety/Usage Agreements, Legal, Coverage Analysis, IRB submissions, etc.).
  • Performs a final review and screening of research submissions (e.g: IRBs, FDA, IBC, SRC) to ensure studies meet regulatory approval; screens revised applications and resubmissions, reviews changes, and approves or makes corrections as needed; attends compliance regulatory meetings (such as IRB) to advise on regulatory and policy issues, and analyze board discussion for action taken on research projects.
  • Consults with and advises faculty and investigators and research teams on regulatory submissions, submitting on their behalf and maintaining their regulatory binders in electronic format to facilitate remote monitoring; interprets and advises on applicable policies, procedures, guidelines, federal regulations, and other compliance-related requirements.
  • Acts as a liaison between committees and chairpersons (IRB), investigators, and various university stakeholders (such as Office of Research Administration (ORA), Office of Research Compliance (ORC) including the Radiation Safety Office, Conflict of Interest Committee, etc. as necessary); ensures investigators and research teams are aware of submission requirements and deadlines.
  • May serve as a mentor, advisor, educator, and/or resource to other research compliance teams and/or staff across the statewide research network, including personnel at, but not limited to, IU Health Arnett, Ball, Bloomington, Methodist, University, North, West, Saxony, Bedford, Schwarz Cancer Center, and Simon Cancer Center, providing necessary education and training to both internal and external researchers, research staff, and other research compliance staff, as needed.
  • Develops and executes Corrective And Preventative Action Plans (CAPAs) to ensure areas of noncompliance are properly addressed with individual researchers and teams.
  • May serve as Research Manager for assigned special projects where additional support is required. This includes managing oversight of the entire research project from start to finish.
  • Creates, develops, and implements new research tools via REDCap to streamline and improve research operations across the spectra, including IU Health Research Billing Error Reporting Tools, Remote Consenting, PI Oversight Plans, Quality Improvement, and more.
  • Serves as Subject Matter Expert and Resource for the development and rollout of new research platforms, such as Advarra eReg and Cognizant Shared Investigator Platform.
  • Manages 30+ protocols annually, submitting all IRB-required regulatory submissions, supporting 20+ different investigators and their research staffs.
  • Facilitates 2 Statewide Research Meetings to coordinate multisite and multi-institutional collaboration: the first is a monthly IU/IU Health Research Meeting with staff from IU Simon Comprehensive Cancer Center, IU, and IU Health Arnett, Ball, Bloomington, and Methodist staffs to coordinate multisite protocols; the second meeting is a monthly meeting to align the policies and SOPs of research institutions across the state, including IU, IU Health, Eskenazi, Indiana Veteran's Administration, Parkview Research, Purdue University, and Deaconess Hospital (OCR Quality and Compliance Workstream).
  • Directs, oversees, and manages the creation, review, and submission of research protocols, Expanded Access Programs (EAPs/Compassionate Use), Humanitarian Use Devices (HUDs), and other protocols that follow the research submission pathway from start-up to closeout across the Statewide Research Network. The Statewide Research Compliance Leader may also handle these tasks directly. These duties include, but are not limited to:
    • Verifying Data Use Agreements with IU Health to use, access, and publish IU Health data; if no agreement is in place, complete and submit DUAs to ensure compliance.
    • Creating and managing IU Affiliate Accounts of IU Health staff and external resources.
    • Managing all institutionally-required compliance training records on staff, including, but not limited to: Human Subject Safety Training, Good Clinical Practice (GCP) Training, IU Conflict of Interest, HIPAA Training, Biosafety Training (Bloodborne Pathogen, Hazardous Goods Shipping, Lab Safety, etc.), Medical Licenses, and Curricula Vitae. Each document has different expiries requiring constant monitoring to ensure compliance and prevent premature study closure.
    • Completing and submitting FDA-required forms (such as 1572s, 3926, IDE/NDA/PMA, etc.).
    • Routing protocols for OCR Coverage Analysis to ensure legal requirements are fulfilled.
    • Registering protocols for OnCore entry and managing IRB records and PowerTrials, updating OnCore after each IRB review and staff change and ensuring required data exports to Cerner for subject Safety.
    • Registering subjects in OnCore and updating their accounts as they progress through the protocol.
    • Drafting Informed Consent Forms, HIPAA Authorization, and essential research documents, facilitating sponsor review and submission to the IRB(s) of record and other regulatory boards as required.
    • Assisting with Feasibility Reviews to ensure site selection by sponsor, completing System Validation, Site Resource, and IRB Information forms.
    • Scheduling and coordinating Site Selection Visits and Study Initiation Visits, ensuring sponsor, site(s), investigator, and staff are able to attend and document training.
    • Submitting new protocol applications to the IRB(s) of record and communicating review status and requirements to sponsor, PI, study team, and IRB reviewers.
    • Completing additional review board applications, including, but not limited to: Office of Research Imaging, Institutional Biosafety Committee, Radiation Safety, and Scientific Review Committee.
    • Preparing Investigator Oversight plans to ensure subject safety, staff support, and compliance with all departmental and institutional policies.
    • Scheduling and facilitating internal meetings and communications with study team to coordinate pre-trial and trial operations.
    • Traveling to remote sites within Statewide Network to ensure all required resources are in place and staff are trained, and to conduct regular monitor and auditing for quality.
    • Compiling all laboratory compliance documentation, such as CAPs, CLIAs, CVs, and Reference Values.
    • Conducting biweekly and monthly study coordinator and PI oversight meetings to ensure PI Oversight plan is followed and staff are in compliance with applicable requirements.
    • Building and maintaining an electronic regulatory binder for both staff and sponsor to access.
    • Coordinating with Budget, Finance, and Contract teams to ensure all preclinical and clinical agreements have been completed.
    • Providing ongoing regulatory compliance and support for studies once the study is fully activated; this includes reviewing and submitting all amendments, continuing reviews, prompt reports, study updates, and closures to the IRB(s) and regulatory boards as required.
    • Coordinating with Investigational Drug Services (IDS) to receive, process, and store drugs in accordance with manufacturing requirements.
    • Establishing workflows of how to conduct trial to ensure efficacy, good clinical practice, and compliance with all applicable regulations.
    • Managing Electronic Data Capture (EDC) systems or other sponsor-required systems to ensure all authorized staff have access.
    • Registering protocol in SIP (Shared Investigator Platform) or other sponsor-required eReg systems as needed.
    • Maintaining log of all sponsor and staff communications to ensure an accurate study record.
  • Performs ongoing regulatory compliance maintenance for active protocols, including, but not limited to:
    • Maintaining all record logs including Delegation of Authority Logs, Training Logs, Adverse/Serious Adverse Event Logs, and Protocol Deviation/Non-compliance Logs.
    • Regularly communicating with sponsor monitors and auditors, providing timely responses to documentation requests.
    • Addressing prompt-reporting requirements for Adverse/Serious Adverse Events, Protocol Deviations/Non-compliance, and External Safety Reports to the IRB(s) of record.
    • Revising all informed consent and HIPAA Authorizations to ensure institutional and state requirements are fulfilled; maintaining strict version control in regulatory binders and serving as liaison between study team, sponsor, and applicable regulatory board during consent revision and approval process.
    • Logging and documenting all sponsor, regulatory board, and internal study communications for compliance and archival purposes.
    • Providing ongoing training to study team staff for protocol amendments, sponsor platform updates, and other requirements.
    • Maintaining accurate training log of all staff and regularly reviewing to prevent compliance; following up with each staff to ensure training (HSP, GCP, CV, ML, FDF/COI, etc.) have been completed, filed, and resent to sponsor.
    • Updating OnCore and ensuring pipeline to Cerner via PowerTrials is accurate and providing safety data for subjects.
    • Ensuring eRegulatory binder (and/or other eReg systems as needed) is current with all IRB and sponsor-approved files; maintaining archive of previously-approved files for audit trail.
    • Submitting Continuing Review forms to the IRB(s) of record in timely fashion, reporting all non-promptly reportable information as required.
    • Attending staffing meetings and addressing any study staff needs with sponsors.
    • For INDs/EAPs- ensuring PI is regularly submitting all FDA-required documentation in alignment with FDA requirements.
  • Travels to sites to audit regulatory and subject records to ensure ongoing compliance and data quality; plan and implement CAPAs and staff training when deficiencies are discovered.
  • Manages non-standard protocols for IU, IU Health, and IUSCCC, including Expanded Access Protocols, Compassionate-Use Protocols, Humanitarian-Use Device Protocols, and Emergency Use Protocols: each protocol requires all action items for the above-listed study start-up process and continuous monitoring for safety, compliance and FDA requirements. Serves as liaison for PI and patient to the IRB(s), FDA, and required safety boards.
  • Advises student research protocols from IU and IU Health employees, assists identifying advising PIs, facilitates research compliance training, provides protocol development guidance, submits to the IU IRB on their behalf, and manages subject OnCore registration.
  • Supports collaborative Purdue-IU/IU Health research by managing IIT regulatory needs, ensuring staff training is sufficient for both IU IRB and Purdue IRB requirements, coordinates communication between the IRBs, submits IU IRB submissions, and manages OnCore subject registration.
  • Serves as the Central Administrator for IU and IU Health in the Shared Investigator Platform (SIP), facilitating new site and protocol registration, assisting feasibility analysis, entering regulatory documents, maintaining facility and staff information, and providing ongoing training to staff. Liaises with Cognizant and SIP Partners (Lilly, Roche, Merck, BMS, etc.) to ensure alignment with shifting SIP expectations and requirements.
  • Assists with the training and onboarding of new research personnel across the state, managing their IU Affiliate Account, providing regulatory training, and training on research platforms (KP, OnCore, REDCap, etc.).
  • Creates training resources for investigators and research staff across the state. Hosts training sessions to ensure consistent training standards.
General 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 and informs employment decisions for assigned staff.
  • Provides direct supervision and oversight of assigned staff and activities; impacts, and is held accountable for, the performance of 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 as well as significant problems.

Qualifications

EDUCATION

Required
  • Bachelor's degree (preferably in related field)
WORK EXPERIENCE

Required
  • 2 years experience consulting and advising on research compliance
Combinations of related education and experience may be considered

SKILLS

Required
  • Proficient communication skills
  • Maintains a high degree of professionalism
  • Demonstrated 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
  • Requires knowledge of applicable laws, regulations, and policies pertaining to compliance programs

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

Indianapolis, Indiana

Benefits Overview

For full-time staff employees, Indiana University offers a wide array of benefits including:
  • Multiple plan options for medical insurance
  • Dental insurance
  • Health Savings Account with generous IU contribution
  • Life insurance, LTD, and AD&D options
  • Base retirement plan contribution from IU, subject to vesting
  • Additional supplemental retirement plan options
  • Tuition benefit for IU classes
  • 10 paid holidays per year
  • Generous Paid Time Off
  • Paid Parental Leave
  • Employee Assistance Program (EAP)
Learn more about our benefits by reviewing our online Benefits Brochure.

Job Classification

Career Level: Operational

FLSA: Exempt

Job Function: Research

Job Family: Research Compliance

Click here to learn more about Indiana University's Job Framework.

Posting Disclaimer

Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.

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.

New employees will be provided with information regarding Indiana University's COVID-19 vaccine policy, which includes the opportunity to request an exemption. To learn more, view our COVID-19 vaccine information page.

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.

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 iups@iu.edu or by visiting IUPD.

Contact Us

Request Support
Telephone: 812-856-1234


This job has expired.

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