Clinical Research Nurse - Pediatric Pulmonology

Department

PED-PULMONOLOGY (IN-PPUL-IUINA)

Department Information

The Division of Pediatric Pulmonology, Allergy and Sleep Medicine in the Department of Pediatrics at IU School of Medicine is a national leader in clinical care, teaching and research in pediatric respiratory medicine. As the only comprehensive pediatric respiratory medicine program in Indiana, this team of faculty pediatricians cares for children throughout the state and regionally.

Job Summary

This position will initiate, conduct, completion and reporting of outcomes of moderate to complex clinical research in the section of Pediatric Pulmonary, Allergy and Sleep Medicine. Coordinate and implement clinical trial activities including staff training, data submission, adverse event reporting. Develop processes to ensure that study procedures are completed appropriately. Address and find solutions to problems with clinical research trials and the ability to conduct the protocols. Monitor regulatory and standard operating procedures and Good Clinical Practice compliance.

Primary Responsibilities Include:

• Follow up/ Schedule study subjects.
• Perform study interviews.
• Conduct study-related clinical procedures and interventions.
• Ensure proper collection, processing, and shipment of specimens.
• Review serious adverse events.
• Collaborate with physicians and other care givers in the collection of clinical data.
• Monitor for protocol compliance.
• Prepare for and manage monitor visits.
• Understand and follow IRB guidelines.
• Educate staff regarding scientific aspects of the study.

Fundamental Responsibilities:

• Assists 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 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, Principal Investigator, 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 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

EDUCATION / WORK EXPERIENCE

Required

• Bachelor's degree in nursing and 1 year of clinical nursing experience OR
• Associate's degree in nursing and 3 years of clinical nursing experience OR
• High school diploma or GED with LPN and 4 years of clinical nursing experience

Combinations of related education and experience may be considered.

LICENSES AND CERTIFICATES

Required

• LPN Licensed Practical Nurse Upon Hire

Preferred

• ACRP or SOCRA Clinical Research Certification Upon Hire

SKILLS

• 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

Job Classification

Career Level: Career

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

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Posting Disclaimer

Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.

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.

New employees will be provided with information regarding Indiana University's COVID-19 vaccine policy, which includes the opportunity to request an exemption. To learn more, view our COVID-19 vaccine information page.

Equal Employment Opportunity

Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment without regard to age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information.

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