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Clinical Research Nurse Supervisor (Department of Surgery)
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Posted Job Title
Clinical Research Nurse Supervisor (Department of Surgery)
Job Profile Title
Supervisor, Clinical Research Nurse
Job Description Summary
The day-to-day responsibilities of the Clinical Research Nurse Supervisor include, but are not limited to, recruitment and enrollment (i.e., pre-screening patients, explaining the trial to patients and their families [e.g., in clinic, ICU/patient rooms, and/or over the phone], consenting patients if appropriate, and confirming eligibility in conjunction with Investigators); completing paper case report forms (CRFs), abstracting data from electronic health records, and conducting telephone visits per protocol; maintaining contact with/tracking study participants per protocol throughout their participation; inputting data into electronic CRFs in a dedicated electronic data capture (EDC) system; responding to regulatory and operational queries in a timely manner; safety monitoring and submitting AEs, SAEs, and UADEs reports to the Investigator, Abramson Cancer Center (ACC)- if applicable, FDA, and Institutional Review Board (IRB) per protocol, federal, and institutional guidelines; device/drug accountability activities in conjunction with the Investigational Drug Service at UPHS and/or device supplier; data collection and vendor oversight in the OR per institutional policies; ongoing study maintenance and oversight within institutional/study systems such as PennCTMS, PennChart, and sponsor EDC platforms; regularly reporting study progress to investigators and other managers upon request; collection, storage, and shipping/delivery of biospecimens per protocol and institutional policies; reviewing and approving research billing; organizing, maintaining, and assuring the accuracy of all study documentation including qualification materials/certifications; and preparing for and participating in study meetings and site visits (i.e., Site Selection Visits, SIVs, monitoring, and audits).
Job Description
The Clinical Research Nurse Supervisor will coordinate the conduct of the Department of Surgery clinical trials by managing and supporting all regulatory and operational aspects of the device and/or drug trials, as well as other research projects as assigned. The Nurse Supervisor will complete data management activities such as eCRF (i.e., forms) creation, maintenance, and version control, preparing data for DSMB meetings and FDA reports, and ensuring all data queries and monitor and/or audit findings are addressed in a timely manner. In addition to acting as a liaison between the University of Pennsylvania and other sponsors and agencies, the Nurse Supervisor will also be responsible for collaborating with faculty in the analysis of clinical data to determine response and clinical outcomes. The Nurse Supervisor will assist with study start-up activities such as assisting budget development, drafting protocols, establishing workflows, providing progress updates to CROs, Sponsors, and Investigators, and creating SIVs. The Nurse Supervisor will also be responsible for preparing all regulatory documentation for assigned studies. The Nurse Supervisor will also assist with the hiring, onboarding, and management of the Department of Surgery Clinical Research Unit clinical research coordinators and research assistants.
The day-to-day responsibilities of the Clinical Research Nurse Supervisor include, but are not limited to, recruitment and enrollment (i.e., pre-screening patients, explaining the trial to patients and their families [e.g., in clinic, ICU/patient rooms, and/or over the phone], consenting patients if appropriate, and confirming eligibility in conjunction with Investigators); completing paper case report forms (CRFs), abstracting data from electronic health records, and conducting telephone visits per protocol; maintaining contact with/tracking study participants per protocol throughout their participation; inputting data into electronic CRFs in a dedicated electronic data capture (EDC) system; responding to regulatory and operational queries in a timely manner; safety monitoring and submitting AEs, SAEs, and UADEs reports to the Investigator, Abramson Cancer Center (ACC)- if applicable, FDA, and Institutional Review Board (IRB) per protocol, federal, and institutional guidelines; device/drug accountability activities in conjunction with the Investigational Drug Service at UPHS and/or device supplier; data collection and vendor oversight in the OR per institutional policies; ongoing study maintenance and oversight within institutional/study systems such as PennCTMS, PennChart, and sponsor EDC platforms; regularly reporting study progress to investigators and other managers upon request; collection, storage, and shipping/delivery of biospecimens per protocol and institutional policies; reviewing and approving research billing; organizing, maintaining, and assuring the accuracy of all study documentation including qualification materials/certifications; and preparing for and participating in study meetings and site visits (i.e., Site Selection Visits, SIVs, monitoring, and audits).
Qualifications:
Registered Nurse; licensure in Commonwealth of PA, Minimum of 5 years experience. BSN, MSN or equivalent combination of education and experience required.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$74,476.00 - $117,086.00
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.
Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits
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