Clinical Research Nurse Leader, Neurology

Department Information

Department NEUROLOGY (IN-NEUR-IUINA)
Department Information The Indiana University (IU) School of Medicine Department of Neurology has a rich tradition in academic neurology with a national reputation in neurological education and neuroscience research. The department is located in the IU Health Neuroscience Center, a state-of-the-art outpatient center that unites all the specialties that involve nervous system disorders:
Neurology, Neurosurgery, Physical Medicine and Rehabilitation, Neuropsychology and Neuroradiology. It is also home of the main outpatient Neurophysiology laboratory at IU Health. The adjoining IU School of Medicine Neurosciences Research Building enables clinicians, basic scientists and clinician-scientists to collaborate in an environment that is rarely achieved in academic medicine.

• 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) (PI), 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, Institutional Review Board (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

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.

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

• Registered Nurse (RN) licensure in Indiana upon date of hire
• Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire

• Proficient communication skills
• Maintains a high degree of…