Job Description
- Assists Principal Investigator (PI) and participates in protocol development, evaluation, and review of risk assessment; evaluates study design and risk to subject population; determines staff, facility, and equipment availability; assesses study population/availability.
- Designs recruitment strategies for each assigned study; recruits subjects according to Institutional Review Board (IRB)/protocol approved methodologies; consents subjects including discussion of treatment and intervention alternatives; monitors enrollment goals and modifies recruitment strategy as needed.
- Liaisons with health-care professionals/providers to determine best recruitment practices for study; manages subject recruitment including marketing, screening procedures, and enrollment.
- Ensures proper collection, processing, shipment of specimens, and documentation; communicates with laboratory, PI, and sponsor regarding laboratory findings; records and documents protocol deviations; communicates with PI and sub-investigators about changes in the trial.
- Participates in preparation and negotiation of study budget and reconciles study budget accounts.
- Reviews, critically evaluates, and comments upon study contracts/agreements.
- Prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary).
- Schedules study-related meetings and training sessions and provides instruction to study team for specific study assignments; educates staff regarding scientific aspects of study and trains ancillary staff regarding clinical studies or trials; monitors study team compliance with required study procedures and Good Clinical Practice (GCP) standards.
- Manages research study inventory and supplies (such as medications, equipment, devices) and maintains required compliance documentation.
- Composes and submits continuing review/amendments/close out information; schedules and prepares for monitor visits; prepares and responds to Sponsor and/or FDA audits.
- Stays up-to-date and maintains current knowledge of regulatory affairs and/or issues; maintains a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings.
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
Required - Bachelor's degree in nursing plus 1 year of clinical nursing experience; OR
- Associate's degree in nursing plus 3 years clinical nursing experience; OR
- High school diploma or equivalent (such as HSED or GED) plus 4 years of clinical nursing experience
LICENSES AND CERTIFICATES
Required - Licensed Practical Nurse (LPN) upon date of hire
Preferred - Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire
SKILLS
Required - Ability to simultaneously handle multiple priorities
- Experience in a regulated environment
- Demonstrates a high commitment to quality
- Ability to analyze and interpret financial data
- Effective interpersonal skills
- Ability to build strong customer relationships
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.
Work Location Indianapolis, Indiana
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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Job Tags
Full time, Work experience placement, Flexible hours