University Hospitals
Protocol Nurse, Dahms Clinical Research Unit
University Hospitals, Cleveland, Ohio, us, 44199
Description
A Brief Overview
Under minimal supervision, DCRU protocol nurse must be self-motivated, process and timeline driven to be responsible for managing the DCRU portion of new clinical research protocol implementation process and amendment maintenance process (for protocols using DCRU nursing and facility services).
DCRU Protocol Nurse will distill clinical research protocol into visit-specific tasks to create: What You Will Do
Team-building skills to be able to interact and communicate collaboratively and effectively with study teams, investigational drug services and other Clinical Research Center cores to implement a new protocol within the timelines requested by the Principal Investigator; Clinical and research nursing skills to create process-driven documents; Writing skills with good spelling and grammar to be able to translate protocol-specific tasks into documents the DCRU nurses and study teams will follow to schedule and conduct study visits. Leadership skills to lead protocol conferences and guide and train DCRU clinical nurses in the use of study equipment and conduct of patient visits Understanding of the research subject as a volunteer, with the goal of the DCRU to provide research patient service excellence and customer service excellence to study teams and collaborators. Demonstrates understanding of the clinical research process and associated regulations for study team conduct of research, to be able to map DCRU nursing process to protocol needs; Performs nursing-specific budget review of protocol request.
Compares study-team-requested nursing visit tasks to available DCRU Services.
Adds DCRU-specific tasks into DCRU finance budget template to allow finance to create budget for submission to study team/Research Finance Services within specified UHCRC timelines; Creates study specific order sets, source documents, and scheduling request forms Establishes and maintains collaborative communications with the principal investigator, sponsor, study coordinator, internal constituents, and interdisciplinary team members. Leads protocol conferences with study teams and collaborative UH research cores to confirm logistics and tasks of protocol-specific visits and follows-up on action items until completed Educates DCRU staff in study procedures and use of study specific equipment Communicates status updates on protocol implementation.
Maintains databases for tracking metrics and progress in protocol implementation Manages time to meet study-requested study start-up timelines for study implementation DCRU Nurse task list for budget, Physician Orders for patient visits, source document flowsheets for DCRU nurse data collection, patient visit scheduling forms used by the study teams, and Protocol Training instruments that meet the protocol training needs of the DCRU staff nurses to be in clinical research regulatory compliance for protocol training. Additional Responsibilities
Performs other duties as assigned. Complies with all policies and standards. For specific duties and responsibilities, refer to documentation provided by the department during orientation. Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace. Qualifications
Education
(BSN) Bachelor's Degree in Nursing
(Required) Work Experience
3+ years Progressive responsibility for protocol-driven clinical research experience as evidence of ability to assume responsibility of DCRU protocol nurse role.
(Required) and 5+ years Nursing experience in the acute setting (Required) and Oncology nursing experience (Preferred) and 3+ years In a clinical research nursing environment demonstrating increasing responsibility in translating protocol requirements into nursing tasks, conducting and documenting those tasks. (Required) Knowledge, Skills, & Abilities
Public speaking (giving PowerPoint presentations or running protocol driven meetings) (Required proficiency) Strong clinical nursing process skills and DCRU research nursing process skills to be able to translate protocol requirements into DCRU nursing practice (Required proficiency) Attention to detail and accuracy. (Required proficiency) Excellent problem-solving nursing process skills to guide nursing patient care team in developing logistical solutions to protocol implementation challenges. (Required proficiency) Time management skills to establish priorities, and manage multiple tasks within a team environment to meet timelines (Required proficiency) Excellent verbal, written and listening communication skills to interact pleasantly and collaboratively with other UHCRC clinical research cores and study teams (Required proficiency) Demonstrated computer skills to effectively use videoconferencing tools, with proficiency in Microsoft WORD, EXCEL, and OUTLOOK, and how to navigate through UH databases for relevant protocol information including UH Intranet for patient care policies and standard of care practices, IRB database, DCRU WEBCamp, oncology OnCore, REDcap and UH CTMS. (Required proficiency) Clinical research documentation practice. (Required proficiency) Knowledge of 12-lead ECG machine use (Required proficiency) Knowledge of various IV pumps and their use (Required proficiency) Licenses and Certifications
Registered Nurse (RN), Ohio and/or Multi State Compact License
Upon Hire (Required) and Basic Life Support (BLS)
(Required) and ACRP Certified Professional (ACRP-CP)
(Preferred) or Society of Clinical Research Associates (SoCRA)
(Preferred) CREC certification to include Human Subjects Protection and Good Clinical Practice (GCP) within 90 Days (Required) and Current chemo/biotherapy administration card for work on oncology research studies.
(Required) Physical Demands
Standing Frequently Walking Frequently Sitting Rarely Lifting Frequently 50 lbs Carrying Frequently 50 lbs Pushing Frequently 50 lbs Pulling Frequently 50 lbs Climbing Occasionally 50 lbs Balancing Occasionally Stooping Frequently Kneeling Frequently Crouching Frequently Crawling Occasionally Reaching Frequently Handling Frequently Grasping Frequently Feeling Constantly Talking Constantly Hearing Constantly Repetitive Motions Constantly Eye/Hand/Foot Coordination Constantly Travel Requirements
10%
A Brief Overview
Under minimal supervision, DCRU protocol nurse must be self-motivated, process and timeline driven to be responsible for managing the DCRU portion of new clinical research protocol implementation process and amendment maintenance process (for protocols using DCRU nursing and facility services).
DCRU Protocol Nurse will distill clinical research protocol into visit-specific tasks to create: What You Will Do
Team-building skills to be able to interact and communicate collaboratively and effectively with study teams, investigational drug services and other Clinical Research Center cores to implement a new protocol within the timelines requested by the Principal Investigator; Clinical and research nursing skills to create process-driven documents; Writing skills with good spelling and grammar to be able to translate protocol-specific tasks into documents the DCRU nurses and study teams will follow to schedule and conduct study visits. Leadership skills to lead protocol conferences and guide and train DCRU clinical nurses in the use of study equipment and conduct of patient visits Understanding of the research subject as a volunteer, with the goal of the DCRU to provide research patient service excellence and customer service excellence to study teams and collaborators. Demonstrates understanding of the clinical research process and associated regulations for study team conduct of research, to be able to map DCRU nursing process to protocol needs; Performs nursing-specific budget review of protocol request.
Compares study-team-requested nursing visit tasks to available DCRU Services.
Adds DCRU-specific tasks into DCRU finance budget template to allow finance to create budget for submission to study team/Research Finance Services within specified UHCRC timelines; Creates study specific order sets, source documents, and scheduling request forms Establishes and maintains collaborative communications with the principal investigator, sponsor, study coordinator, internal constituents, and interdisciplinary team members. Leads protocol conferences with study teams and collaborative UH research cores to confirm logistics and tasks of protocol-specific visits and follows-up on action items until completed Educates DCRU staff in study procedures and use of study specific equipment Communicates status updates on protocol implementation.
Maintains databases for tracking metrics and progress in protocol implementation Manages time to meet study-requested study start-up timelines for study implementation DCRU Nurse task list for budget, Physician Orders for patient visits, source document flowsheets for DCRU nurse data collection, patient visit scheduling forms used by the study teams, and Protocol Training instruments that meet the protocol training needs of the DCRU staff nurses to be in clinical research regulatory compliance for protocol training. Additional Responsibilities
Performs other duties as assigned. Complies with all policies and standards. For specific duties and responsibilities, refer to documentation provided by the department during orientation. Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace. Qualifications
Education
(BSN) Bachelor's Degree in Nursing
(Required) Work Experience
3+ years Progressive responsibility for protocol-driven clinical research experience as evidence of ability to assume responsibility of DCRU protocol nurse role.
(Required) and 5+ years Nursing experience in the acute setting (Required) and Oncology nursing experience (Preferred) and 3+ years In a clinical research nursing environment demonstrating increasing responsibility in translating protocol requirements into nursing tasks, conducting and documenting those tasks. (Required) Knowledge, Skills, & Abilities
Public speaking (giving PowerPoint presentations or running protocol driven meetings) (Required proficiency) Strong clinical nursing process skills and DCRU research nursing process skills to be able to translate protocol requirements into DCRU nursing practice (Required proficiency) Attention to detail and accuracy. (Required proficiency) Excellent problem-solving nursing process skills to guide nursing patient care team in developing logistical solutions to protocol implementation challenges. (Required proficiency) Time management skills to establish priorities, and manage multiple tasks within a team environment to meet timelines (Required proficiency) Excellent verbal, written and listening communication skills to interact pleasantly and collaboratively with other UHCRC clinical research cores and study teams (Required proficiency) Demonstrated computer skills to effectively use videoconferencing tools, with proficiency in Microsoft WORD, EXCEL, and OUTLOOK, and how to navigate through UH databases for relevant protocol information including UH Intranet for patient care policies and standard of care practices, IRB database, DCRU WEBCamp, oncology OnCore, REDcap and UH CTMS. (Required proficiency) Clinical research documentation practice. (Required proficiency) Knowledge of 12-lead ECG machine use (Required proficiency) Knowledge of various IV pumps and their use (Required proficiency) Licenses and Certifications
Registered Nurse (RN), Ohio and/or Multi State Compact License
Upon Hire (Required) and Basic Life Support (BLS)
(Required) and ACRP Certified Professional (ACRP-CP)
(Preferred) or Society of Clinical Research Associates (SoCRA)
(Preferred) CREC certification to include Human Subjects Protection and Good Clinical Practice (GCP) within 90 Days (Required) and Current chemo/biotherapy administration card for work on oncology research studies.
(Required) Physical Demands
Standing Frequently Walking Frequently Sitting Rarely Lifting Frequently 50 lbs Carrying Frequently 50 lbs Pushing Frequently 50 lbs Pulling Frequently 50 lbs Climbing Occasionally 50 lbs Balancing Occasionally Stooping Frequently Kneeling Frequently Crouching Frequently Crawling Occasionally Reaching Frequently Handling Frequently Grasping Frequently Feeling Constantly Talking Constantly Hearing Constantly Repetitive Motions Constantly Eye/Hand/Foot Coordination Constantly Travel Requirements
10%