RN-Clin Research Nurse
The RN-Clinical Research Nurse in the Lewis Katz School of Medicine'sNeurology/Neurosurgery Departments/CRA will be responsible for theday-to-day activities surrounding clinical research studies, and willensure compliance with federal, state and university regulations.The incumbent will work with the department’s faculty investigators onmultiple active protocols and will interact closely with the sponsorsfrom qualification visits to close-out visits.
Responsibilities include: performingnursing assessments and procedures, such as conductingcomprehensive nursing assessments, obtaining vital signs, reviewingmedications, assessing patient and family educational and clinical needs; documentingpatient information/instructions in the medical record, completing appropriateforms; performing any procedures required for the patient such as drawingblood, inserting IV's, conducting EKG's etc.; collecting and interpretingclinical and research information related to the patient visit; appropriatelyfield/triage patient telephone calls regarding medication changes, clinicalstatus, prescription renewals, changes in condition etc.; assisting with datacollection for ongoing clinical research trials, researching protocols andadministrative needs; participates, with the PI, in the review and preparationof protocols for clinical trials; reviews protocols in conjunction with the PI,submits all/any changes to sponsor and IRB, coordinates all changes to consentforms and all research documents serving as a liaison between PI, Sponsor, CRAand IRB; maintains regulatory documentation and manages IRB submissionsand follow-ups; recruits and enrolls study subjects for active clinical trials;research nurse participates in clinics and enrolls patients as appropriate fromthe clinic as well as the inpatient setting. In addition, the RN-ClinicalResearch Nurse educates residents and nursing staff on protocols and reviewsinpatient census regularly triaging for appropriate research candidates; obtainsinformed consent from participants and ensures that signed consent and otherstudy related documentation (e.g. questionnaires, case report forms, etc.) arefiled in the appropriate trial regulatory binder with patient and PI signatures;coordinates study visits with the PI, and schedules patient admissions relatedto study procedures; serves as a patient advocate, and educates andcounsels patients and families on the details and expectations for clinicaltrial compliance to include visits, testing, medications, case report formcompletion and compensation related to visits; ensures that clinical trials arefollowed by clinical research staff by monitoring folders and informing staffof pertinent research updates from IRB, sponsor and regulatory agencies in atimely manner; monitors patient care, and assesses patient status and treatmentside effects throughout the study period to ensure patient safety and properstudy conduct; communicates changes to patient status to the PI and researchteam in a timely manner, and follows up with patient regarding treatmentchanges or variations to the protocol; documents progress and conversations inall appropriate research documents and medical record; oversees data collectionand management, in the medical record system and study binders, in accordancewith trial protocol; prepare and update regulatory binders for auditsfrom the IRB and regulatory agency audits and sponsor monitoring visits; distributesdebit cards/study compensation to participants and tracks & documentspayments in appropriate manner; contacts Administration for additional cards,as needed; attends and presents updates at regulatory clinical trial meetingswith the PI, Senior Administrator and research team; reports serious adverseevents to the IRB, sponsor and Dept Administration; assists with budget preparation and tracking of expenditures;monitors study and subject trial progress and invoices the sponsor at thevarious payment intervals as designated in the budget spreadsheet for trialpayments. Performs other duties as assigned.
Required Education and Experience:
Professional licensure as aRegistered Nurse in the Commonwealth of PA, with previous research experiencein a research and/or clinical trials setting.
Required Skills and Abilities:
RequiredSkills and Abilities:
*Ability to apply scientific principles toproblem solving, planning, as well as providing and evaluating nursing care.
*Working knowledge of computer applicationsincluding MS Office.
*Ability to work independently and as part of aninter-disciplinary team.
*Demonstrated interpersonal, communication, andcustomer service skills.
*Proven organizational and time managementskills with a strong attention to detail.
*Ability to travel to other off-site clinicalsites.
*Bachelor’s degree in Nursing.
*ACLS or BLS certification.
*Experience in a critical care setting or neurosciencespreferred.
Thisposition requires a background check.
TempleUniversity values diversity and is committed to equal opportunity for allpersons regardless of age, color, disability, ethnicity, marital status,national origin, race, religion, sex, sexual orientation, veteran status or anyother status protected by law.
ComplianceStatement: In the performance of their functions as detailed in the positiondescription employees have an obligation to avoid ethical, legal, financial andother conflicts of interest to ensure that their actions and outside activitiesdo not conflict with their primary employment responsibilities at theinstitution. Employees are also expected to understand and be in compliancewith applicable laws, University and. employment policies and regulations, includingNCAA regulations for areas and departments which their essential functionscause them to interact.
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Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)
Shift: Day Job
Employee Status: Regular