Clinical Research Nurse C/D (OBGYN - GYN Oncology)

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey.

Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

• Posted Job Title
• Clinical Research Nurse C/D (OBGYN - GYN Oncology)
• Job Profile Title
• Clinical Research Nurse C

Job Description Summary

Research Nurse C/D is a key clinical research position responsible for coordinating and managing all aspects of clinical trial conduct to ensure the safe, compliant, and efficient execution of research studies.

This role involves overseeing the proper reporting of serious and non-serious adverse events to sponsors and regulatory bodies, coordinating the administration and monitoring of investigational products and study medications, and managing all study-related scheduling, documentation, and data collection.

Research Nurse C/D works closely with the Principal Investigator to prepare study documents, regulatory submissions, source templates for trial initiation and ongoing operations.

Additional responsibilities include assisting with protocol development for logistical feasibility, ensuring accurate transcription of study data into case report forms, coordinating subject visits and procedures, and providing mentorship and support to unit staff.

This position plays a critical role in maintaining regulatory compliance, protecting participant safety, and supporting high-quality clinical research.

The Clinical Research Nurse provides input into the development of efficient work flows, helps develop internal budgets for sponsored trials,. Attends study meetings develops internal strategies for meeting and exceeding trial enrollment, and assures compliance with regulatory standards.

The Clinical Research Nurse provides oversight for research medication administration, monitors patient care, treatment of side effects and patient status throughout the study period and communicates with research team, including PIs, CRC and regulatory team to ensure patient safety and proper study conduct.

Job Description

Job Responsibilities

Clinical Research Nurse C

Coordinate the conduct of Phase I – IV clinical trials including screening and enrolling eligible subjects, follow GCP guidelines in the conduct of trials, coordinate implementation of research protocols with study and clinical team, collecting and reporting research data, reporting serious adverse events per protocol, coordinate subject care with clinical team, provide coverage and support to other research nurses and coordinators

Managing subject treatment per protocol, oversight and coordination of research testing, including labs, office visits and radiology exams, provide oversight for research medication administration, monitor patient care, treatment side effects and patient status throughout study period, communicate any research issues to PI

Participate in research team meetings, assist with staff /study team education, participate in study-related meetings

Provide coverage and support to other research nurses and coordinators to meet departmental/organizational staffing needs

Develop and maintain ongoing communication with the clinical teams including, but not limited to: laboratory, infusion, radiology, Advanced Practitioners, triage, inpatient and pharmacy. Provide in-service and support to infusion, CHPS or inpatient staff as appropriate. Provide ongoing service education updates to all investigators and HUP staff that have eligible participants for clinical research trials

Other duties and responsibilities as assigned

Clinical Research Nurse D

Provides clinical oversight for the investigational product administration and ensuring absolute adherence to complex trial protocols; This role is responsible for the technical integration of clinical care and research, managing intricate administration timelines with rigorous post-infusion safety monitoring for adverse events. Beyond bedside coordination, the position serves as the primary clinical lead for the unit by drafting Beacon treatment plans and collaboration with the Center for Human Phenomic Science (CHPS) and investigational pharmacy units to optimize workflows

Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures. Manage collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events

Ensure proper screening and enrollment of all study participants. With oversight of the PI, participate in the informed consent and confirming subject study eligibility prior to participation

Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel according to applicable regulations and policies

Ensure preparation of study related document templates (e. g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), patient list (enrollment log) for study start up

Assist with protocol implementation to ensure logistical feasibility of all study related procedures and study workflows

Meet with Principal Investigator routinely to discuss study related issues and to ensure completion of study related procedures. Ensure preparation of all required study related documents for submission to all applicable institutional committees for review and approval to start trial

• Orient and mentor new unit staff and function as resource for current staff
• Other duties and responsibilities as assigned

*Position Contingent upon funding *

Qualifications

Position requires an individual with excellent oral and written communication skills. The candidate should possess the ability to work independently and also as part of a team. Strong planning, organizational and prioritizing capabilities along with problem solving skills desired. Must be able to work flexible hours.

Previous research experience and knowledge of IRB processes, human research protection regulations, and regulatory management preferred. Background in oncology preferred.

Clinical Research Nurse C: Registered Nurse with Licensure in Commonwealth of Pennsylvania without restriction or limitation. Bachelor’s degree and 2 to 3 years of experience or equivalent combination of education and experience required. BSN preferred

Clinical Research Nurse D: Registered Nurse with Licensure in Commonwealth of Pennsylvania without restriction or limitation. Bachelor’s degree and 4 to 5 years of experience or equivalent combination of education and experience required. BSN preferred

• Job Location - City, State
• Philadelphia, Pennsylvania
• Department / School
• Perelman School of Medicine

Pay Range

$63,085.00 - $104,809.00 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 famil