Job Description Summary

Responsible for implementing clinical research activities within the Cardiovascular Division of PPMC. The clinical research nurse will participate in clinical studies in interventional and vascular cardiology. Coordinates investigational protocols under the supervision of Administrative Director and Principal Investigator. Major responsibilities include but not limited to obtaining detailed knowledge of all components of trial protocols, screening and enrolling patients, conducting follow-up…

activities, performing phlebotomy to collect samples from patients, abstracting medical and demographics data from medical records, completing source documents and case report forms, data entry using various electronic data collection system, managing the adverse event reporting process and assisting with the regulatory and financial management of multiple studies. Coordinate several investigational device trials in the cath lab, instruct and support investigators and study staff on carrying out clinical protocol and other study related requirements

Job Description

This position is contingent upon favorable funding.

Job Responsibilities

Assist in research studies using approved protocols, according to GCP. Familiarize with all components of study protocols by review of study, related literature prior to start. Attend Investigators Meetings. Assure accurate, completion and updates of the Delegation of Duties and Authorized Signatures Form. Confer with the pharmacist as needed to assure the availability of study drug. Create, maintain research data, regulatory files.
Timely initiation of screening, enrolling patients. Screen to identify potential patients for specific studies, determine patient eligibility by communicating with physicians, clinical staff and by reviewing medical records to validate potential patient data against Inclusion /Exclusion checklists. Recruit patients, explain protocol, consent forms. Assure original signed consents are maintained in the study binder. Complete screening/enrollment logs and submit to sponsor, as protocol.
Schedule and conduct follow-up visits with patients and assure research team availability to assure all follow-up activities are conducted within sponsor designated time frames including documentation of follow-up efforts. Schedule additional protocol-required tests/procedures.
Create and maintain a complete and accurate regulatory binder for each study. Prepare and process all regulatory documentation with research sponsors and clinical research organizations (CROs). Obtain the appropriate signatures for regulatory forms.
Perform Phlebotomy to collect blood samples of study patients. Centrifuge blood specimens and separate into transfer vials according to sponsor specifications. Ship blood and urine specimens to study-specific central labs according to Transportation of Dangerous Goods regulations.
Complete all source documents and worksheets within 48 hours of study activity. Complete and/or enter all clinical record forms (CRFs) within 5 working days or less depending on sponsor requirements. Create and maintain subject binders. Obtain records required to complete CRFs. Assure inclusion of enrollment information, research orders, and other communications are entered into the electronic medical record of each subject. Resolve data queries with sponsors/CROs.
Monitor adherence to protocol throughout enrollment in study. Notify Pl, RPM, and sponsor of any deviations from protocol or adverse events. Assure trial data are accurate, complete, verifiable from source documents; collect data on adverse events ,reports serious adverse events per regulatory standards. Assure timely notification to all enrolled subjects of significant changes in consents. Assure all study drugs/devices/equipment are maintained in a secure manner.
Resolve regulatory related queries with IRB, study sponsors. Review Research bills/invoices for accuracy for payment from research revenue fund account.
Prepare source document worksheets to facilitate data collection for each new study.
Create and maintain study spreadsheets to track enrollment, treatment, treatment assignment, adverse events, follow-up visits/calls, create databases in electrophysiology dept.
Provide in service training and education to PPMC in-patient/cath lab cardiology nurses and patient care staff in all aspects of trial, procedures, clinic visits. Provide subject and family education and support. Ensure subjects are educated regarding the protocol specifics and study drugs/devices.
Other duties and responsibilities as assigned.

Qualifications

Bachelor's degree and 1-2 years of experience along with Registered Nurse with Licensure in Commonwealth of Pennsylvania without restriction or limitation required. BSN preferred.

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Clinical Research Nurse B

University of Pennsylvania

University of Pennsylvania, Philadelphia, PA, USA

Job Description Summary

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Clinical Research Nurse B

University of Pennsylvania