University of Pennsylvania
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TITLE/GRADE: Clinical Research Nurse B/26
(exempt)
SOURCE OF SUPERVISON:
Supervisor, Clinical Research Nurses
DUTIES:
This individual will work under direct supervision.
Clinical Research Nursing Responsibilities
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Assist in coordinating the conduct of Phase I – IV clinical trials for patients.
Provide oversight of administration of medications, study drugs, or study interventions, as
appropriate.
Provide oversight and coordination of radiographic imaging and laboratory findings.
Conduct assessment and collect medical history.
Monitor patient care, assess patient status, and monitor treatment side effects.
Coordinate activities of team in caring for patients. Coordinate patient visits and any necessary
testing.
Provide patient and family education and support. Ensure patients are educated regarding the
protocol specifics and study drugs.
Consent patients for clinical trials. Follow Good Clinical Practices (GCP) guidelines.
Assist in coordinating the development of research protocols and treatment plans with physicians,
pharmacists, other nurses, research coordinators, and pharmaceutical companies.
Active participation in the development of investigator initiated protocol case report forms and
progress notes.
Demonstrate vigilance in patient safety, protocol compliance, and data quality.
Assist in conducting initiation, monitoring, and close-out visits with sponsors and/or Clinical
Research Organizations (CROs).
Recruit and screen potential study patients as specified per assigned protocols. Confirm patient
eligibility and registration.
Complete case report forms (CRFs), and resolve data queries with sponsors and CROs.
Obtain records required to complete CRFs.
Process and ship blood, urine and serum specimens for each trial.
Obtain diagnostic materials such as slides from pathology and/or scans from radiology and ship
to sponsor/independent review per protocol guidelines.
Attend investigator and site initiation meetings.
Adhere to all University of Pennsylvania, Informed Consent Form (ICF), and FDA guidelines.
May travel to research sites.
Regulatory Responsibilities
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Assist in preparing and processing all regulatory documentation through the Institutional Review
Board (IRB) and other entities as required, including amendments, continuing reviews, and
adverse event reporting.
Assist in preparing and processing all regulatory documentation with pharmaceutical companies
and clinical research organizations (CROs).
Resolve regulatory related queries with IRB, study sponsors, and CRO.
Participate in the conduct of audits by study sponsors, CROs, the FDA, and other groups.
REQUIREMENTS: EXPERIENCE, CREDENTIALS AND SKILLS
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Registered Nurse: Licensure in Commonwealth of Pennsylvania.
One year prior experience in clinical research/clinical trials research preferred.
BSN preferred.
Effective problem-solving abilities
Effective communication and writing skills.
Knowledge of IRB and human research protection regulations, preferred.
COMPETENCIES:
Action Oriented; Boss Relationships; Ethics and Values; Integrity and Trust; Interpersonal Savvy;
Learning on the Fly; Listening; Organizing; Planning; Priority Setting; Self-Knowledge; Standing Alone;
Technical Learning; Time Management