Clinical Research Nurse II

Department:

Location:

Health Sciences Center

Time Type:

Full time

Worker Type:

Regular

Job Req ID:

R106225

Minimum Requirements:

Bachelor's degree in Nursing with current Kentucky license and two (2) years of related research or nursing experience. If not ACRP or SoCRA certified should obtain the certification within the first three years. Grade 8 (Salaried)

Position Description:

The Clinical Research Nurse II will coordinate the prospective clinical research studies conducted in the Department of Neurosurgery at the University of Louisville. The studies may be clinical trials testing treatments, multicenter, and focus on a wide range of diseases, including cerebrovascular, neuro-oncological, trauma, and neurological recovery.  The nurse will be the central to these studies, working directly with the Principal Investigators (PIs) leading these studies and entities necessary for successful conduct of the studies. Among the entities the nurse will interact with include regulatory bodies of the University of Louisville, data analysts, trial participants, personnel at other sites, and the University of Louisville or Jewish Hospital infrastructure and its clinical personnel.

Essential Duties and Responsibilities:

• Works collaboratively with and acts as a liaison for Principal Investigators (PIs) of the studies, regulatory bodies of the University of Louisville, data analysts, trial participants, personnel at other sites, and the University of Louisville or Jewish Hospital infrastructure and its clinical personnel.

• Specific jobs will include coordination of site startup activities, providing regulatory assistance to the sites for single IRB process; the coordination and delivery of site protocol training for study specific procedures; helping with central pharmacy planning of drug shipping and stocking; facilitation of scheduling and leading site readiness calls; helping with planning national steering committee meetings; coordinate meetings with scientific advisory board; contributing to the ongoing monitoring of recruitment and retention, posting trial development on clinical trials.gov, and assisting with other ongoing communication with sites including newsletters and webinars, communication with the sponsor about all aspects of study as requested.

• Work closely with PI on clinical coordination and the data management center for data coordination.

• Assist the study Contact PI in broad oversight of all administrative aspects of the trial such as communication with the Institutional Review Board, Data and Safety Monitoring Board, and Sponsors.

• Works with trial participants to consent and obtain data from them.

• Hold study specific trial contact line and answers calls regarding the study and study protocol.

• Calls trial participants to obtain data from them. Enters data in clinical record forms for the studies.

• Establishes timelines, targeted completion dates, workflow, and process guidelines for studies.

• Supervises other study personnel and participates in the process of performance evaluation.

• By working with financial administrators, monitors financial accountability of ongoing grant awards, purchasing, reporting of financial progress, consultant payments and other network expenses.

• Completes, monitors, and oversees progress reporting.

• Maintains timely communications including, but not limited to, website development, educational functions, email distributions and teleconferences.

• Monitors, oversees, and develops standard operating procedures and policies.

• Collaborates with the institutional review board (IRB).

• Collaborates with personnel of the biorepository at the University of Louisville.

• Collaborates with hospital central pharmacy.

• Monitors and oversees network agreements and relations with SRS and university general counsel.

• Participates in study governance as a member of the Executive and Steering committees.

• Works with the financial administrators on new clinical trials to establishes fees for new clinical trials (e.g. contracting, IRB, central pharmacy, etc.)

• Works with PIs and financial administrators to develop per-patient budgets and site start-up fees for preliminary budgets for studies.

• Participates in meetings specific to the studies.

• Completes and submits the necessary regulatory correspondence, progress and safety monitoring, and reporting to regulatory agencies in a timely manner.

• Participates, as needed, in clinical trial site assessments including, but not limited to, site initiation visits, closeout visits, and regulatory or performance audit visits.

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