Job Summary

Department Specific Responsiblities

• Provides overall direction and strategy for the Neuroscience Institute Clinical Trials Office (CTO).
• Responsible for oversight and direction of research processes for departments in the Neuroscience Institute; Neurology, Psychiatry, Neurological Surgery, Physical Medicine and Rehabilitation and Otolaryngology.
• Establishes CTO standard operating procedures and best practices and oversee implementation and compliance.
• Responsible for general oversight of research teams budgetary and fiscal management.
• Resource for the University, industry sponsors, NSI faculty and staff. As the primary liaison between the Clinical Trials Office and sponsors, collaborators, regulatory agencies, and administrative stakeholders.
• Ensures effective communication, successful study execution, and regulatory compliance.
• Serves as the Neuroscience Institute's representative and liaison with IU Health's statewide clinical research initiatives, promoting alignment, collaboration, and growth across the health system's research programs.

General Responsibilities

• Provides a high level of direction and oversight for clinical research operations; ensures successful administration, operations, and financial management; establishes and drives execution of priorities in alignment with stakeholder, senior leadership, and researcher expectations; provides systematic direction for all clinical trial operations to ensure the organization meets all compliance measures as set forth in the clinical research studies provided by the sponsor.
• Supervises clinical research staff and conducts a variety of personnel actions to include, but not limited to hiring, training, promotion, performance management, and dismissal.
• Provides direction for engagement with staff, other departments involved in research initiatives, internal and external customers, other health care systems, and other academic institutions to address project and program development and quality assurance while conducting clinical research which meets all federal, state, and university guidelines.
• Evaluates protocol, study design and feasibility for subject population; determines staff and facility availability and resources and operationalization of proposed clinical trials; assesses study population/availability; develops, executes, and revises recruitment strategies as needed to ensure enrollment targets are met; monitors enrollment goals and modify recruitment strategy as necessary; schedules and coordinates pre-study visits with sponsor/s.
• Performs subject interviews and assessments at study visits for data required by protocol; ensures proper collection, processing, shipment, and documentation of data (or specimens); communicates with laboratory, Principal Investigator(s), and sponsor(s) regarding laboratory findings.
• Ensures inventory of study resources; prepares and negotiates budget; prepares payment schedule with sponsor(s); negotiates fees for associated services; manages study account and ensures that expenditures do not exceed contracted amount; monitors for appropriate charges; reconciles study budget accounts with business/financial administrator; ensures adherence to grant sponsors, IRB and university accounting and grant administration guidelines.
• Prepares various reports (such as accrual, patient demographics, and diagnoses), as needed, along with other subjects for principal investigator(s), senior leaders and/or stakeholders who may require the information for inclusion in new or continuing grant applications.
• Provides oversight and ensures proper management of all software and database systems used for the tracking and invoicing clinical trials; plans and establishes continued usage of any current or new clinical research systems.
• Researches and stays up-to-date with new research developments by attending continuing education meetings, lectures, training sessions and conferences.

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/ WORK EXPERIENCE

Required

• Master's degree plus 2 years of clinical research experience including supervisory experience OR
• Bachelor's degree plus 5 years of clinical research experience including supervisory experience

LICENSES AND CERTIFICATES

Required

• RN Licensure in Indiana Upon Date of Hire
• Clinical Research Certification (ACRP or SOCRA) Upon Date of Hire

SKILLS

Required

• Proficient written and verbal 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
• Demonstrates excellent judgment and decision making skills
• Effective conflict management skills
• Builds and manages effective teams

Working Conditions / Demands

This role requires sedentary work as well as extended durations of moving about the workplace. It requires the ability to move objects and equipment weighing up to 25 pounds, and the ability to discern between various objects and devices and to position patients. The person in this role must be able to perform the essential functions with or without an accommodation.

Benefits Overview

For full-time staff employees, 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)

Learn more about our benefits by reviewing the IU Benefit Programs Brochure .

Job Classification

Career Level: Sr. Operational

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

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.

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