Description

The Department of Psychiatry at Indiana University School of Medicine is committed to understanding the symptoms and neurobiological basis of mental illness and advancing psychiatric treatments through extensive involvement in basic and clinical research and patient care. The department is also involved with educating and training future leaders of psychiatry and behavioral science.
Indiana University School of Medicine is the largest medical school in the United States, with a large academic health center in downtown Indianapolis, the 17th largest city in the United States. In addition to having active sports, cultural, arts, and educational events and programs, Indianapolis is located centrally near several other major cities including Chicago, Louisville, Cincinnati, and Columbus.
IU School of Medicine is closely aligned with our health system partner, IU Health, which has twice earned a place on the US News and World Report Honor Roll. The shared vision of both institutions is to lead the transformation of healthcare through quality innovation and education to make Indiana one of the nation's healthiest states. IU Health is among the top 10 largest single-state nonprofit health systems in the United States operating 16 hospitals statewide (a mix of urban, suburban and rural facilities). This partnership enables the seamless integration of research findings into patient care.

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 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 2 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

• SOCRA/ARCP 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 .

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 [email protected] or by visiting IUPD.