Clinical Research Nurse B

Clinical Research Nurse B

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

• 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.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$53,418.00 - $73,825.00 Annual Rate

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
• Tuition : Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
• Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
• Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
• Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.