Clinical Research Coordinator, Neurology

Indiana University; Indianapolis (IN); On-site; USD 52,000 - 75,000; Full time

Benefits offered by this job

Health insurance

Tuition subsidy

Generous paid time off

Job summary

Indiana University’s School of Medicine, Department of Neurology, is seeking a Research Coordinator to support clinical studies. You will review protocols, design studies, and assess risks, while helping negotiate budgets and preparing regulatory documents for IRB submissions.

You will recruit and screen subjects, conduct interviews, monitor enrollment, and ensure compliance with regulations and sponsor requirements. Strong organizational skills and attention to quality are essential.

Qualifications

• Bachelor's degree in science or health-related field with 1 year of clinical research experience, or an Associate's degree with 3 years of clinical research experience.
• SOCRA/ACRP clinical research certification preferred at date of hire.
• Combinations of related education and experience may be considered.

Responsibilities

• Initiates and conducts protocol review, study design and risk assessments for clinical studies.
• Participates in study budget negotiations and reconciles budget accounts.
• Develops materials to recruit subjects and monitors enrollment goals.
• Prepares IRB and regulatory documents for sponsor and submissions.
• Identifies, screens and interviews potential subjects for protocols.
• Follows up on study documentation with healthcare providers and participants.
• Reviews SAE information and assists PI with determinations and follow-up.
• Performs study-related assessments and procedures as applicable.
• Records protocol deviations and trials changes; stays updated on regulatory issues.

Skills

Analytical

Multi-tasking

Technical aptitude

Quality commitment

Organizational skills

Education

Bachelor's degree in science/health field

Associate's degree in science/health field

Job description

The Indiana University (IU) School of Medicine (IUSM) 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 IUSM Neurosciences Research Building enables clinicians, basic scientists and clinician-scientists to collaborate in an environment that is rarely achieved in academic medicine.

Job Summary

• Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
• Participates in study budget negotiations and reconciles study budget accounts.
• Develops informational materials for recruitment of subjects. Monitors enrollment goals and modifies recruitment strategy as needed.
• Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately. Prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary). Prepares regulatory documents for sponsor.
• Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews. Performs subject interviews and assessments for data required by protocol(s).
• Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.).
• Reviews incoming subject adverse event (SAE) information, assists Principal Investigator (PI) in making submission determination of SAEs, and follows up to determine resolution of adverse events.
• Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
• Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
• Stays up to date with knowledge of regulatory affairs and/or issues.

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

• Bachelor's degree in science or a health-related field and 1 years of clinical research experience; OR
• Associate's degree in science or a health-related field and 3 years of clinical research experience.

Licenses and Certificates

Preferred

• Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire.

Skills

Required

• Demonstrates analytical skills.
• Ability to simultaneously handle multiple priorities.
• Possesses strong technical aptitude.
• Demonstrates a high commitment to quality.
• Excellent organizational skills.

Working Conditions / Demands

The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. 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: Career

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

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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.

Equal Employment Opportunity

Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information .

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