Project Nurse, Vascular Surgery

POSITION SUMMARY:

Under the direct supervision of the Vascular Surgery Division Chief, and the Director of Vascular Surgery Research, with direction from the Vascular Surgery Project Nurse; with latitude, the Project Nurse manages study protocols including many complex interventional device or drug therapy treatments. The Vascular Surgery Project Nurse oversees, coordinates and provides support for Industry Sponsored Clinical Trials and Investigator Initiated Research Studies for the Division of Vascular Surgery and the Complex Aortic Care Center. Ensures Regulatory and Protocol Compliance for each Study Protocol. Develops, implements and monitors systems and methods to ensure quality, integrity, safety, efficiency, and consistency in the processing of human subject research data. This position offers many opportunities for professional and personal growth.

TYPICAL DUTIES:

• Oversight and Coordination: Supervises research staff and participates in the coordination of research subjects enrolled in clinical studies through the full lifecycle of the study, from site selection and start up to study visit conduct and closeout. Recruits, consents, schedules research subject visits for complex studies (device, drug, or hybrid trials) involving greater than minimal risk to subjects in accordance with the study protocol.

• Utilizes problem-solving skills to develop, implement, and evaluate subject recruitment and retention strategies. Utilizes RN nursing assessment skills to ensure subject compliance with medications, conduct ECGs, cognitive assessments, (NIHSS, Modified Rankin, etc.), imaging follow-up and other protocol-specific tasks. Coordinates with Research Pharmacy for Drug Studies; and documents dispensing and return of study drugs/materials for drug studies; Coordinates and documents receipt/use/return of study devices for device studies.

• Works with PI and multidisciplinary teams for the provision of any additional resources needed to conduct study procedures. Coordinates and communicates with Sponsors, Study Monitors, and the Vascular Team with clear verbal and written communications. Maintains documentation; creates study source documentation as needed if not provided by sponsor. Updates consents and re-consents subjects as needed per study protocol.

• Study Subject Visits: Oversees and conducts Subject study visits in compliance with Study Protocols. Accountable for collecting data in OR, during procedures in compliance with protocol. Coordinates orders in eRecord with Investigators and arranges upcoming subject visits. Manages and ensures accurate source data in Sponsor’s or Investigator’s eDC system (electronic data capture system). Clarifies and resolves data queries. Prepares for scheduled sponsor monitoring visits (i.e., pre-study inspection, initiation, SIV, ongoing visits and close-out/secure storage). Understands, implements, and provides training to the VS Team on study protocols (e.g., amended protocol), understand medical procedures, confirms documentation based on Sponsor and FDA standards, & per BOMA recommendations so FDA inspection ready at all times.

• Financial: Develops Study Budgets; Works closely with the PI; Research Administration and Office of Clinical Research (OCR) to develop, negotiate study budgets in accordance with UR and ORPA requirements. Responsible for overseeing data entry into OnCore; Confirming Invoices to be sent; performs Research Billing Review for the study subjects. Reviews study progress, monitors scope of work related to the budget. Coordinates with OCR for Pre-Award and Post-Award work as needed. Coordinates with Surgery Research Administrator as needed for NDA/CDA, IORA entry; processing documents through ORPA to open and close studies; confirming all payments received.

• Study Start-up Activities: Oversees and coordinates all study start-up activities: Organizes and participates in Site Feasibility tours, and meetings as needed. Coordinate with Sponsor on Site ICF (Informed Consent Form), Obtain signatures and forward Essential Documents to Sponsor, coordinate and attend SIV (Site Initiation Visit) and Training. Creates and / or revises Informed Consent Forms and study documents as needed in compliance with FDA CFR title 21, FDA Good Clinical Practice (GCP) and UR RSRB and / or Central IRB requirements. Utilizes problem-solving and time management skills,

• Regulatory Compliance/ Coordination – Ensures all regulatory and institutional requirements are met and documented. Obtains appropriate RSRB and/or central IRB approval for study start-up. Plans, develops, modifies, approves, and maintains regulatory and study documentation. Ensures the integrity and security of all study documents at all times. Initiates, monitors and ensures that regulatory activities are standardized across studies. Implements immediate and appropriate corrective action when inconsistency of activities is identified. Manages and submits study applications, amendments, and continuing reviews for IRB approval. Oversees the storage of archives, destruction of documents; and maintenance of current study documents per study requirements.

• Coordinates with Vascular QI as needed.

• Serves as the liaison between cross-functional research team, study sponsors, and IRB to facilitate communication, resolve issues, and enhance collaboration. Maintains ongoing communication with all relevant stakeholders. Utilizes self-initiative and problem solving skills to troubleshoot and resolve issues in a timely manner. Represents the University and Principal Investigator at study meetings as needed. Participates on hospital committees and work groups as requested or as self-identified opportunities (with approval from Director of Research) to represent Vascular Surgery and special needs of device studies at the UR are identified. Coordinate and communicate with Industry Sponsors, the Vascular Team, and interdisciplinary team members with clear verbal and written communications.

• Demonstrates accountability for continuous learning related to clinical research. Keeps current with study-specific training, including understanding of specific details of study protocols, all relevant sponsor and institutional policies, guidelines and standard operating procedures. Attends training sessions and other educational opportunities related to clinical research in order to stay current with Good Clinical Practice (GCP) guidelines, federal and state policies and laws, institutional certifications, industry standards and best practices; and trends in relevant therapeutic areas. Maintain NYS Professional Registered Nurse Licensure; and other certifications as required by various studies.

Other duties as assigned.

QUALIFICATIONS:

• Bachelor’s Degree in related field required;

• Minimum AAS RN Nursing degree, BSN RN (preferred)

• RN Nursing, minimum 1 - 2 years nursing experience, surgical / hospital experience preferred.

• Project Management Experience

• Or equivalent combination of education and experience

• Skills: Microsoft WORD, EXCEL, eRecord, EMR required

• Abilities: excellent attention to detail; accurate data entry skills; highly organized, excellent problem-solving skills, critical thinking skills, excellent time management skills required

• Knowledge of: CTMS Forte OnCore, all 3 modules: Protocol, Subjects, Financial preferred, required to obtain

• CLICK IRB preferred, required to obtain

• NYS Registered Professional Nurse License (Required)

• CITI Certification – UR Human Subjects Training, (must be obtained online during first 30 days of Onboarding) required to obtain

• NIHSS - NIH Stroke Scale Certification (must be obtained during first 30 days of onboarding) required to obtain

• GCP Training (obtained at same time as CITI Certification) required to obtain

• Professional Certification: SOCRA or ACRP (If not certified at time of employment, expectation is that this will be obtained when eligible - typically after 2 years of Research Coordination Experience)

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.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $ 66,602 - $ 93,205 Annually

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 044 Surgery Research