Job location: Perelman Center-FL7

Employment Type: Full-time
Posted data: 2019-09-09
Req: JR00004711
University Overview

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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

Job Profile Title

Clinical Research Nurse C

Job Description Summary

The Clinical Research Nurse C reports to the Director of Clinical Research Operations for Dermatology. This position is responsible for the initiation and follow-through of study procedures for new investigator-initiated and industry-sponsored clinical trials. Manage all aspects of Phase I-IV clinical trials. Participate in the conduct of monitoring visits and audits by study sponsors, CROs, the FDA, the University of Pennsylvania’s CRSRMC, and other groups.
Develop and maintain ongoing communication with the CSU team as well as partnered laboratories, infusion centers, radiology department, and investigational drug service pharmacy. Provide in-service and support to infusion/CHPS staff as appropriate. Administer and/or provide treatment agents or study interventions as appropriate. Review all clinical and laboratory data and adverse events, reporting in real-time to the PI for assessment and review.
Handle any questions subjects may have regarding protocol specifics, investigational products, lab results, effects of therapies, medications and symptoms management within the level of expertise and referring other questions to the PI in order to obtain guidance or assistance.

If needed, collect, review and report timely, valid accurate study data within the timelines specified by the clinical trial agreement. Complete study evaluation, data collection, assessments, source documentation, adverse event reporting, and case report forms. Perform necessary screening and routine evaluations in clinical trials including phlebotomy, physical assessments, EKGs, or other activities as indicated. Coordination may also include: obtaining and processing of specimens, submission of study documents to all applicable institutional committees (e.g., IRB, CTSRMC, CHPS) for initial approval, continuing reviews, amendments, and modifications.

Provide coverage and support to other research nurses and coordinators to meet departmental/organization needs. Act as a mentor to newly-hired coordinators. Assist the CSU Director in maximizing the efficiency and quality of research performed, including developing SOPs.

Must remain personally and professionally up-to-date on health care information. Obtain 30 CEUs every two years for RN licensure. To have knowledge of and adhere to all ICH-GCP and University requirements.

Job Description

Independently coordinate, with the support of the study team, state of the art clinical trials, including consenting, screening and enrolling eligible subjects, managing the treatment of patients throughout their participation in the study including education about any adverse effects they might experience, provide oversight and coordination of research testing and follow-up, as well as, in some case, directly administer novel research medications. Monitor the care and progress of patients, the treatment of any side effects and status of patients throughout their participation in the study, in addition to providing patient/family education and support. May assist in the writing and development of investigator-initiated protocols, participate in and possibly lead working groups within the CRU that will maximize the efficiency and quality of research performed within the program, including developing SOPs, educate and train clinical and research staff, serve as a resource for the development of study orders and a resource for junior staff. Provide input into the development of efficient work flows and attend any meetings related to the studies. Develop and institute internal strategies for meeting and exceeding trial enrollment, and assuring compliance with all relevant regulatory standards. Help develop internal budgets for sponsored trials, assisting in the development of investigator-initiated trails.

Responsibilities/Duties

The Clinical Research Nurse C is responsible for conducting studies involving a wide variety of dermatologic related investigational products and with various sponsors or investigators within the Dermatology Clinical Studies Unit. These trials may be Phase I – IV with a focus on early phase trials requiring more extensive clinical expertise. Additionally:

• Supports and interacts with principal and sub-investigators
• Attends study related meetings and conferences
• Effectively communicates with other coordinators, staff, outside departments (e.g., laboratory, infusion, radiology and pharmacy) and outside organization such as Sponsors, CROs.
• Shows vigilance in patient safety, protocol compliance, and data quality.
• Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
• Develops and implements innovative strategies to ensure successful recruitment and enrollment goals are met within specified timelines.

Completes study evaluations, data collection, assessments, source documents, adverse experience reports, and case report forms, perform necessary screening and routine evaluations in clinical trials including phlebotomy, physical assessments, photography, EKGs, or others as indicated within required time frames and with attention to detail according to the protocol. Nurse may also be involved in obtaining and processing of specimens, submission of study documents to all applicable institutional committees (e.g., IRB, CTSRMC, CHPS) for initial approval, continuing reviews and for approval of any amendments, modifications.

Develop and maintain ongoing communication with the CSU team as well as partnered laboratories, infusion centers, radiology department, and investigational drug service pharmacy. Provide in-service and support to infusion/CHPS staff as appropriate. Administer and/or provide treatment agents or study interventions as appropriate. Review all clinical and laboratory data and adverse events, reporting in real-time to the PI for assessment and review.

Handle any questions subjects may have regarding protocol specifics, investigational products, lab results, effects of therapies, medications and symptoms management within the level of expertise and referring other questions to the PI in order to obtain guidance or assistance. This may be done in-person and by telephone.

Provide coverage and support to other research nurses and coordinators to meet departmental/organization needs. Act as a mentor to newly-hired coordinators. Assist the CSU Director in maximizing the efficiency and quality of research performed, including developing SOPs.

Maintain competency professionally and personally. Completes all necessary protocol specific trainings as well as required organizational trainings (Penn CRC, IATA, CPR).

This position is contingent on funding.

Qualifications
Bachelor's Degree with 4-6 years of related experience or equivalent combination of education and experience is required. (5-7 years preferred)

Working Conditions
Office, Library, Computer Room

Physical Effort
Typically sitting at a desk or table; Occasional lifting 25 lb. or less

Contingent upon funding

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$50,684.00 - $91,232.00

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.