Download University of Pennsylvania NOTE: This job description is provided as

University of Pennsylvania
NOTE: This job description is provided as a sample. Be sure to review each item below and
ensure it is appropriate for the specific job you are posting. You may also add items not
included on this list that are specific to the job you are developing.
TITLE/GRADE: Supervisor, Clinical Research Nurses/29 (exempt)
SOURCE OF SUPERVISON:
Administrative Director
DUTIES:
This individual will work independently with minimal supervision.
Supervisory & Administrative Responsibilities: Orientation, Training, Educational Programs










Provide direct supervision to Clinical Research Nurses and other support staff (if applicable) on a
daily to weekly basis depending upon skill level of individual and phase of orientation.
Determine workload and assignments for staff.
Responsible for or participate in the hiring and performance management of staff.
Act as liaison between new hire and department and other entities including HUP, Penn,
pharmaceutical companies, cooperative groups and other departments on the University campus.
Create orientation and training programs, specific to individual new hire’s skill set, educational
preparation, and prior professional experience.
Implement and continually modify a comprehensive orientation program for newly hired research
nurses, during the introductory/orientation period.
Continually assess progress of research nurses through phases of orientation, i.e., clinical, data
management, laboratory, regulatory, at the University of Pennsylvania.
Coordinate and conduct ongoing staff education.
Coordinate and ensure up-to-date staff certification and licensure.
Actively work towards process improvement including assisting in development of IOPs.
Clinical Research Nursing Responsibilities














Coordinate 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.
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 GCP guidelines.
Coordinate 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.
Participate in protocol development; selection and activation of trials
Participate in the determination of protocol feasibility.
Act as liaison with pharmaceutical companies, cooperative groups and other departments on the
University campus.
Conduct initiation, monitoring, and close-out visits with sponsors and/or CROs.









Recruit and screen potential study patients as specified per assigned protocols. Confirm patient
eligibility and registration.
Resolve data queries with sponsors and CROs.
Oversee the obtaining of records required to complete case report forms.
Oversee completion of CRFs.
Oversee the processing and shipping of blood, urine and serum specimens for each trial.
Oversee the obtaining of diagnostic materials such as slides from pathology and/or scans from
radiology and the shipping to sponsor/independent review per protocol guidelines.
Attend investigator and site initiation meetings.
Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
May require travel to research sites.
Regulatory Responsibilities





Prepare and process all regulatory documentation through the Institutional Review Board (IRB)
and other entities as required, including amendments, continuing reviews, and adverse event
reporting.
Prepare and process all regulatory documentation with pharmaceutical companies and clinical
research organizations (CROs).
Resolve regulatory related queries with IRB, study sponsors, and CRO.
Conduct initiation, monitoring and closeout visits with sponsors and/or CROs.
Participate in the conduct of audits by study sponsors, CROs, the FDA, and other groups.
REQUIREMENTS: EXPERIENCE, CREDENTIALS AND SKILLS










Registered Nurse: Licensure in Commonwealth of Pennsylvania.
At least 5 years of clinical trials/clinical research experience.
A BSN and MSN, preferred.
Management and supervisory experience preferred.
Staff education and orientation experience preferred.
Effective problem-solving abilities
Effective communication and writing skills.
Ability to multi-task.
Demonstrated ability to work as part of a team as well as function independently.
Knowledge of IRB and human research protection regulations
COMPETENCIES:
Action Oriented; Command Skills; Conflict Management; Confronting Direct Reports; Delegation;
Directing Others; Hiring and Staffing; Informing; Integrity and Trust; Managerial Courage; Priority Setting;
Problem Solving; Process Management; Standing Alone; Building Effective Teams