Research Nurse-Urology Clinical Trials Group

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ESSENTIAL FUNCTIONS

Clinical Study Visits and Clinical Assessments:

• Conducts unstructured interviews with subjects and families as required by protocol; perform clinical research related procedures (blood draws and Intravesical Instillations); measures, records, and reports indicators of patient health status; perform more specialized tasks such as Bladder Scans, Void Trials, Catheter Changes and Uroflowmetry; evaluates subjects for local or systemic reactions to determine adverse events to study medication or vaccine.
• Discuss with subjects’ potential adverse events and SAEs and participating in grade of events.
• Participate in the reporting of subject serious adverse events (SAE) and filing of these in a timely manner to sponsors and IRBs.

Subject Recruitment

• Identification of subject pool, eligibility screening in clinic settings and/or telephone screens; medical history review; obtain informed consent and proceed with enrollment procedures; answers patient questions to ensure he/she understands the clinical study and their involvement.
• Participate in performing all protocol required study procedures on subjects which include but are not limited to venipuncture, urine collection, Bladder Scans, Uroflowmetry, and Intravesical Instillation. Review and interpret study guidelines for next steps necessary for the processing and/or shipment of samples.
• Track and prepare requests for payments to subjects

Clinical Study Visits

• Ensures assigned studies are conducted accurately, conducts subject visits per protocol which may include standard-of-care visits, performs clinical research procedures (i.e., blood draw, urine sample collection), prepares, stores, and ships biological specimens, requests tissue from Pathology, verifies laboratory data, distributes study medication per protocol, documents adverse events accurately, consults with study investigators, regularly interacts with clinic, off-site, and laboratory staff as it pertains to subject visit requirements, follows subject visits.

Research Team Collaboration

• Attend and participate in study team meetings, monthly research group meetings, and participate in unique sponsor-required training prior to study start; establish and maintain relationships with sponsor representatives for the purpose of regulatory compliance and quality assurance/control.
• Organizes, develops, implements, evaluates, and manages all study documentation and multi-use electronic forms using Excel or Word. 
• Completes source documentation and CRF’s, enters data into various database websites, ensures accurate and complete information within specific timeframe, monitors and tracks subject visits via multiple spreadsheets.

Study Management/Regulatory/Quality Assurance

• Oversees Quality Assurance and Control to optimize ID site study performance.
• Makes recommendations and implements changes to improve site study performance.
• This includes but is not limited to source document verification and ensuring its accuracy and compatibility with case report form information.
• QA of charts to ensure subjects meet all of the eligibility requirements for study participation relating to GU Cancer, Kidney stones, infertility and other Urology related diseases and disorders; ensure procedures are performed per protocol and confirm that no deviations from protocol have occurred.
• Ensures that all source document information is completed accurately and includes all information required by the study sponsor.
• Manages and oversees assigned studies, fully participates in the planning, development and implementation of study design, protocols, consent forms, study logistics, study budgets, quality assurance and other programs. 
• Reconciles invoices, initiates subject payments in compliance with protocol. 
• Conducts quality assurance activities. 
• Acts as liaison with study monitors, provides data clarifications, communicates with sponsor to clarify data queries, participates in sponsor monitoring visits. 
• Ensures regulatory applications are complete and associated documents are developed and submitted to RSRB in a timely fashion. 
• Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. 
• Documents and maintains all study forms electronically or in binders. 
• Communicates with faculty and staff in the Urology
• Department, Wilmot Cancer Institute, RSRB, and various departments within the University relating to management and resolution of study issues.

Other Duties

• May supervise others. 
• Trains staff regarding activities associated with conducting human subject research guidelines and sponsor requirements, attends pertinent research seminars and meetings, inventories study supplies, performs POCT testing, must have own transportation and be willing to travel to off-site offices depending on study requirements.  
• Inventories study supplies, restocks exam rooms and organizes supplies and charts for each individual study protocol; assist with data entry, filing, mailings, source document development and compiling study summary data as needed.
• Keeps current with regulations for conducting clinical studies according to good clinical practices, federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines, and makes recommendations and implements changes as necessary. 
• Other duties as assigned by manager.

REQUIREMENTS

• Bachelor’s degree, RN Licensure and 2 years of clinical trials experience, or an equivalent combination of education and experience. 
• Phlebotomy skills for adult and pediatric patients and good computer skills Independent and organized professional with superior interpersonal skills, sound judgment and good oral and written communication skill.
• Strong attention to detail and must be able to problem-solve effectively. 
• Knowledge of computer databases including eRecord and ePARC, Word and Excel software programs. 
• Professional Research Coordinator Certification (i.e., SoCRA or ACRP) preferred. 

EOE Minorities / Females / Protected Veterans / Disabled:

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law.  This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.