Indiana University
Overview
Clinical Research Nurse at Indiana University. This role supports the conduct of quality clinical research by dermatology clinical investigators from protocol development through study implementation, publication, and long-term follow-up. Responsibilities
Assist Principal Investigator and participate in protocol development, evaluation, and review of risk assessment; evaluate study design and risk to subject population; determine staff, facility, and equipment availability; assess study population/availability. Design recruitment strategies for each assigned study; recruit subjects according to IRB/protocol approved methodologies; consent subjects including discussion of treatment and intervention alternatives; monitor enrollment goals and modify recruitment strategy as needed. Liaise with health-care professionals/providers to determine best recruitment practices; manage subject recruitment including marketing, screening procedures, and enrollment. Ensure proper collection, processing, shipment of specimens; communicate with laboratory, PI, and sponsor regarding laboratory findings; document protocol deviations; communicate with PI and sub-investigators about changes in the trial. Participate in preparation and negotiation of study budget and reconcile study budget accounts; review, evaluate, and comment upon study contracts/agreements. Prepare and submit Institutional Review Board (IRB) documents (e.g., informed consent, advertisement, protocol and protocol summary). Schedule study-related meetings and training sessions; educate staff regarding scientific aspects of the study; train ancillary staff on clinical studies or trials; monitor study team compliance with required procedures and GCP standards. Manage research study inventory and supplies (medications, equipment, devices) and maintain compliance documentation. Compose and submit continuing review/amendments/close out information; schedule and prepare for monitor visits; prepare and respond to sponsor and/or FDA audits. Stay up-to-date with regulatory affairs and maintain knowledge of clinical literature; participate in continuing education, conferences, seminars, and project team meetings. Qualifications and Experience
Education/Work Experience: Bachelor\'s degree in nursing plus at least 1 year of clinical nursing experience OR Associate\'s degree in nursing plus at least 3 years clinical nursing experience OR high school diploma or equivalent with LPN plus at least 4 years of clinical nursing experience. Licenses and Certificates: LPN license upon date of hire. Preferred: ACRP or SOCRA Clinical Research Certification upon date of hire. Skills
Ability to handle multiple priorities; experience in a regulated environment; strong commitment to quality; ability to analyze and interpret financial data; effective interpersonal skills; ability to build strong customer relationships. Additional Role Details
The role requires the ability to move about the work environment, operate laboratory equipment, and occasionally move objects up to 25 pounds. The position must be able to perform essential functions with or without accommodation. Indianapolis, Indiana. Benefits and Employment Details
For full-time staff employees, IU offers comprehensive medical and dental insurance; health savings account with generous IU contributions; flexible spending accounts; basic group life insurance; voluntary supplemental life and other insurances; retirement plan with IU contributions; tuition subsidy for employees and family; 10 paid holidays plus paid winter break; generous paid time off; parental leave and volunteer program leave; employee assistance program. Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See IU Notice of Non-Discrimination for details. The annual security and fire safety report is available online or by request. This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. The 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.
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Clinical Research Nurse at Indiana University. This role supports the conduct of quality clinical research by dermatology clinical investigators from protocol development through study implementation, publication, and long-term follow-up. Responsibilities
Assist Principal Investigator and participate in protocol development, evaluation, and review of risk assessment; evaluate study design and risk to subject population; determine staff, facility, and equipment availability; assess study population/availability. Design recruitment strategies for each assigned study; recruit subjects according to IRB/protocol approved methodologies; consent subjects including discussion of treatment and intervention alternatives; monitor enrollment goals and modify recruitment strategy as needed. Liaise with health-care professionals/providers to determine best recruitment practices; manage subject recruitment including marketing, screening procedures, and enrollment. Ensure proper collection, processing, shipment of specimens; communicate with laboratory, PI, and sponsor regarding laboratory findings; document protocol deviations; communicate with PI and sub-investigators about changes in the trial. Participate in preparation and negotiation of study budget and reconcile study budget accounts; review, evaluate, and comment upon study contracts/agreements. Prepare and submit Institutional Review Board (IRB) documents (e.g., informed consent, advertisement, protocol and protocol summary). Schedule study-related meetings and training sessions; educate staff regarding scientific aspects of the study; train ancillary staff on clinical studies or trials; monitor study team compliance with required procedures and GCP standards. Manage research study inventory and supplies (medications, equipment, devices) and maintain compliance documentation. Compose and submit continuing review/amendments/close out information; schedule and prepare for monitor visits; prepare and respond to sponsor and/or FDA audits. Stay up-to-date with regulatory affairs and maintain knowledge of clinical literature; participate in continuing education, conferences, seminars, and project team meetings. Qualifications and Experience
Education/Work Experience: Bachelor\'s degree in nursing plus at least 1 year of clinical nursing experience OR Associate\'s degree in nursing plus at least 3 years clinical nursing experience OR high school diploma or equivalent with LPN plus at least 4 years of clinical nursing experience. Licenses and Certificates: LPN license upon date of hire. Preferred: ACRP or SOCRA Clinical Research Certification upon date of hire. Skills
Ability to handle multiple priorities; experience in a regulated environment; strong commitment to quality; ability to analyze and interpret financial data; effective interpersonal skills; ability to build strong customer relationships. Additional Role Details
The role requires the ability to move about the work environment, operate laboratory equipment, and occasionally move objects up to 25 pounds. The position must be able to perform essential functions with or without accommodation. Indianapolis, Indiana. Benefits and Employment Details
For full-time staff employees, IU offers comprehensive medical and dental insurance; health savings account with generous IU contributions; flexible spending accounts; basic group life insurance; voluntary supplemental life and other insurances; retirement plan with IU contributions; tuition subsidy for employees and family; 10 paid holidays plus paid winter break; generous paid time off; parental leave and volunteer program leave; employee assistance program. Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See IU Notice of Non-Discrimination for details. The annual security and fire safety report is available online or by request. This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. The 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.
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