Employer: Indiana University Purdue University Indianapolis
Hiring Department: Dermatology
Job Title: Clinical Research Nurse
Additional Information: https://hrms.indiana.edu/psc/PH1PRD_PUB/EMPLOYEE/HRMS/c/HRS_HRAM_FL.HRS_CG_SEARCH_FL.GBL?Page=HRS_APP_JBPST_FL&Action=U&FOCUS=Applicant&SiteId=1&PostingSeq=1&JobOpeningId=309229
Department Information
Indiana University School of Medicine, Department of Dermatology is seeking a Registered Nurse who will function as a Clinical Research Nurse to support and facilitate the conduct of quality clinical research by dermatology clinical investigators from the early stages of protocol development and continue throughout the study implementation, publication, and long-term follow-up.
Job Summary
- Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
- Conducts study visit activities and coordinates screening, consenting, and scheduling of tests, exams, and/or non-medical/behavioral interventions and assessments involving study subjects.
- Identifies and selects potential subjects by reviewing existing protected health information, screen subjects, and conducting interviews; performs subject interviews and assessments for data required by protocol(s).
- Conducts study-related, non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure my apply).
- Reviews incoming subject adverse event (AE) and serious adverse event (SAE) information, assists PI in making submission determination of SAEs, and follows up to determine resolution of adverse events.
- Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
- Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed.
- 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.
- 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.
- 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 nursing with 2 years of clinical nursing experience; OR
- Associate's degree in nursing plus 5 years of clinical nursing experience.
LICENSES AND CERTIFICATES
Required
- RN Registered Nurse upon date of hire.
Preferred
- ACRP or SOCRA Clinical Research Certification upon date of hire.
