RESEARCH NURSE COORDINATOR, INNOVATION

Research Nurse Coordinator, Innovation Quick Apply with Resume upload88 A Brief Overview The Research Nurse Coordinator will support clinical research initiatives of Regional One Health. He/she will be primarily responsible for the planning, coordination, and conducting of product evaluations of 510 (K) cleared medical devices for the Center for Innovation; will complete EMR chart reviews; collect and compile research data; prepare and submit IRB study documents; and occasionally support activities of clinical trials as assigned by study investigators and/or Research/Program Directors. The RNC role is responsible for all assigned research projects from start to study close out; Ensures studies are conducted according to GCP guidelines, IRB and hospital research policies and procedures; serve as point of contact for assigned projects and handle all related communication; utilize clinical expertise and research experience to prepare and complete all required study documentation; work closely with investigators of assigned research projects; travel to local recruitment sites when required, performs all nursing related duties/procedures; and assists with tracking of study activities and distribution of reimbursements. This position may require incumbents to perform Vital Sign, catheterization to collect urine specimens; administer required study medications/placebos; start peripheral intravenous lines, draw blood, process, store, and ship specimens, perform pregnancy tests, EKGs, run centrifuge machines; educate and orient physicians, nurses, and patients to individual study procedures and patient care; assist physician with collection of specimens in operating room; review laboratory results for abnormal values; complete CRFs for each study assigned; and resolve study queries and related issues. What you will do Clinical Responsibilities: # Responsible for patient recruitment, scheduling all research appointments and follow up visits, and enhancement of research subject compliance. # Provides nursing functions as needed (draws blood, starts intravenous lines, performs physicals, vaginal or speculum exams, patient teaching, and schedules required tests). # Extrapolates clinical data from patient charts for review and organizes data in accordance with research goals. # Assures accuracy, completeness, and consistency in data reported, manages data as required and cleans up data for analysis when needed. # Prepares for on-site monitoring of documentation and CRF information and meets with each monitor from each Sponsor for assigned trials to answer questions or resolve data or documentation related issues. # Processes and documents all study related communications. # Manages inventory of study-specific medical devices and/or trial investigational products. # Works with Clinical Pharmacy in planning the delivery/receiving and storage of trial investigational products for assigned trials # Prepares and administers study related medications and monitors for adverse reactions, reviews laboratory results, answers study queries, and resolves study issues. # Oversees or performs processing, storing, and/or shipping of all study related specimens to required location. # Works with other clinical research centers as coordinator in performing clinical trials to schedule appropriate rooms for research subject appointments/visits, rooms for site or monitoring visits, etc. Regulatory Responsibilities: # Provides in-services or training for clinical research personnel, ancillary staff or other personnel as needed. # Creates needed study and site source documents for new projects # Maintains regulatory binder and study records for each assigned clinical studies # Prepares IRB applications and study documents for submission, provides oversight of IRB applications and submissions if performed by other research personnel, assists with initial consent language and ensures accuracy in consent forms. # Ensures that clinical trial contract language is congruent with the Payment and the Compensation # Treatment for Injury sections of assigned trial#s informed consent form when ROH holds the study contract; creates related letter for upload along study documents for initial IRB submission. # Consults with study Principal Investigators, and Research/Program Director (s) prior to initial IRB regulatory submissions for new studies; ensures contracts and budgets are finalized prior to IRB submission. # Complies IRB approved study documents and completes ROH research application forms for review and processing for hospital approval. # Coordinates/Prepares for internal or external site/monitoring visits or audits. # Completes online training and/or certifications for each required module of each study assigned GCP. # Coordinates/attends investigators meetings for trials assigned. # Maintains records of and primary accountability for new protocols, amendments, IB#s and IRB activities/updating Regulatory binder as needed. # Completes research EMR documentation for each enrolled subject (i.e. research consent discussion and procedures notes powerforms). # Tracks and processes Adverse Events (AEs) and Serious Adverse Events (SAEs) per trial assigned. Research Coordination Responsibilities: # Informs study investigators and the Program Director of any new clinical study inquiries and/or requests for feasibility evaluations prior to initiation of related activities; ensures proper process is followed for new study feasibility assessments and ROH#s ability to accommodate new studies. # Works closely with the PIs of each study to meet recruitment goals as required by the sponsoring company of all clinical trials assigned. # Responsible for assisting in troubleshooting and problem solving to address daily problems or issues in a consistent and efficient manner. # Informs PI and Program Director of recruitment and/or randomization of numbers, needs of projects assigned, and unusual occurrences. # Compiles weekly status and statistical reports compiling research findings and compliance with protocols. # Assists in contacting entities for needed services including pharmacy and laboratory services for required processing of specimens. # Assists in obtaining cost estimates for services and logistical planning for implementation of research services for multiple individual protocols. # Assists Director in monitoring of expenditures and earned dollars for each clinical studies assigned. # Keeps up with the details of assigned study protocol (s) and required study services to be rendered by ROH/ROHRI; prepare research services rate request form; work with internal and external departments, as needed, to determine research charge rates for contracting. # Keeps up with study contracts and agreements for assigned trials; maintain log of study services/activities completed; ensure rendered research services are invoiced/paid for according to clinical trial agreements. # Creates and maintain database for assigned clinical trials to include study initiation date, contract status, IRB and ROH approval status, patient enrollment status, etc. # Creates and maintains database of enrolled research subjects to include enrollment date, randomized study group (i.e., treatment vs placebo), consent documentation status (paper and EMR), termination date, etc. Administrative Responsibilities: # Maintains proper and fair scheduling for research personnel assigned to ensure coverage is achieved. # Maintains updated records of permanent leave record forms and obtains and handles requests for vacation, sick, etc. for individuals as required to assist in research coverage. Supervises and oversees research personnel as assigned. # Tracks petty cash needed for research trials and patient reimbursements distributed. # Performs related duties to assist Directors as needed and handles details in a confidential nature Responsible for creation and management of study invoices. # Responsible for preparation and submission of ROH check requests to pay research service providers (i.e. IRB, Pharmacy) for assigned clinical trial services. Responsible for placement of requisitions for research and/or office supplies; maintains record of related orders and invoices for reimbursement. # Lead/assist with the development of study budgets for assigned clinical studies. # Responsible for the coordination and planning of site visits by study monitors and study sponsors, including planning of site visit catering services, facility and IT access needs. Qualifications Graduate of an accredited nursing school/program required. Bachelor#s Degree in nursing Preferred RN - Registered Nurse - State Licensure and/or Compact State Licensure in the state of Tennessee Required Three (3) years clinical experience as a Registered Nurse required. Two years of experience coordinating activities of clinical studies required. Experience supporting clinical studies and implementing multiple concurrent research projects preferred. Strong regulatory expertise and experience working with the IRB preferred. Microsoft Word and Excel experience required. Physical Demands Standing - Occasionally Walking - Occasionally Sitting - Constantly Lifting - Rarely Carrying - Rarely Pushing - Rarely Pulling - Rarely Climbing - Rarely Balancing - Rarely Stooping - Rarely Kneeling - Rarely Crouching - Rarely Crawling - Rarely Reaching - Rarely Handling - Occasionally Grasping - Occasionally Feeling - Rarely Talking - Constantly Hearing - Constantly Repetitive Motions - Frequently Eye/Hand/Foot Coordination - Frequently Regional One Health is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. #

Research Nurse Coordinator, Innovation

Quick Apply with Resume upload88

A Brief Overview

The Research Nurse Coordinator will support clinical research initiatives of Regional One Health. He/she will be primarily responsible for the planning, coordination, and conducting of product evaluations of 510 (K) cleared medical devices for the Center for Innovation; will complete EMR chart reviews; collect and compile research data; prepare and submit IRB study documents; and occasionally support activities of clinical trials as assigned by study investigators and/or Research/Program Directors. The RNC role is responsible for all assigned research projects from start to study close out; Ensures studies are conducted according to GCP guidelines, IRB and hospital research policies and procedures; serve as point of contact for assigned projects and handle all related communication; utilize clinical expertise and research experience to prepare and complete all required study documentation; work closely with investigators of assigned research projects; travel to local recruitment sites when required, performs all nursing related duties/procedures; and assists with tracking of study activities and distribution of reimbursements. This position may require incumbents to perform Vital Sign, catheterization to collect urine specimens; administer required study medications/placebos; start peripheral intravenous lines, draw blood, process, store, and ship specimens, perform pregnancy tests, EKGs, run centrifuge machines; educate and orient physicians, nurses, and patients to individual study procedures and patient care; assist physician with collection of specimens in operating room; review laboratory results for abnormal values; complete CRFs for each study assigned; and resolve study queries and related issues.

What you will do

* Clinical Responsibilities: • Responsible for patient recruitment, scheduling all research appointments and follow up visits, and enhancement of research subject compliance. • Provides nursing functions as needed (draws blood, starts intravenous lines, performs physicals, vaginal or speculum exams, patient teaching, and schedules required tests). • Extrapolates clinical data from patient charts for review and organizes data in accordance with research goals. • Assures accuracy, completeness, and consistency in data reported, manages data as required and cleans up data for analysis when needed. • Prepares for on-site monitoring of documentation and CRF information and meets with each monitor from each Sponsor for assigned trials to answer questions or resolve data or documentation related issues. • Processes and documents all study related communications. • Manages inventory of study-specific medical devices and/or trial investigational products. • Works with Clinical Pharmacy in planning the delivery/receiving and storage of trial investigational products for assigned trials • Prepares and administers study related medications and monitors for adverse reactions, reviews laboratory results, answers study queries, and resolves study issues. • Oversees or performs processing, storing, and/or shipping of all study related specimens to required location. • Works with other clinical research centers as coordinator in performing clinical trials to schedule appropriate rooms for research subject appointments/visits, rooms for site or monitoring visits, etc.
* Regulatory Responsibilities: • Provides in-services or training for clinical research personnel, ancillary staff or other personnel as needed. • Creates needed study and site source documents for new projects • Maintains regulatory binder and study records for each assigned clinical studies • Prepares IRB applications and study documents for submission, provides oversight of IRB applications and submissions if performed by other research personnel, assists with initial consent language and ensures accuracy in consent forms. • Ensures that clinical trial contract language is congruent with the Payment and the Compensation & Treatment for Injury sections of assigned trial's informed consent form when ROH holds the study contract; creates related letter for upload along study documents for initial IRB submission. • Consults with study Principal Investigators, and Research/Program Director (s) prior to initial IRB regulatory submissions for new studies; ensures contracts and budgets are finalized prior to IRB submission. • Complies IRB approved study documents and completes ROH research application forms for review and processing for hospital approval. • Coordinates/Prepares for internal or external site/monitoring visits or audits. • Completes online training and/or certifications for each required module of each study assigned GCP. • Coordinates/attends investigators meetings for trials assigned. • Maintains records of and primary accountability for new protocols, amendments, IB's and IRB activities/updating Regulatory binder as needed. • Completes research EMR documentation for each enrolled subject (i.e. research consent discussion and procedures notes powerforms). • Tracks and processes Adverse Events (AEs) and Serious Adverse Events (SAEs) per trial assigned.
* Research Coordination Responsibilities: • Informs study investigators and the Program Director of any new clinical study inquiries and/or requests for feasibility evaluations prior to initiation of related activities; ensures proper process is followed for new study feasibility assessments and ROH's ability to accommodate new studies. • Works closely with the PIs of each study to meet recruitment goals as required by the sponsoring company of all clinical trials assigned. • Responsible for assisting in troubleshooting and problem solving to address daily problems or issues in a consistent and efficient manner. • Informs PI and Program Director of recruitment and/or randomization of numbers, needs of projects assigned, and unusual occurrences. • Compiles weekly status and statistical reports compiling research findings and compliance with protocols. • Assists in contacting entities for needed services including pharmacy and laboratory services for required processing of specimens. • Assists in obtaining cost estimates for services and logistical planning for implementation of research services for multiple individual protocols. • Assists Director in monitoring of expenditures and earned dollars for each clinical studies assigned. • Keeps up with the details of assigned study protocol (s) and required study services to be rendered by ROH/ROHRI; prepare research services rate request form; work with internal and external departments, as needed, to determine research charge rates for contracting. • Keeps up with study contracts and agreements for assigned trials; maintain log of study services/activities completed; ensure rendered research services are invoiced/paid for according to clinical trial agreements. • Creates and maintain database for assigned clinical trials to include study initiation date, contract status, IRB and ROH approval status, patient enrollment status, etc. • Creates and maintains database of enrolled research subjects to include enrollment date, randomized study group (i.e., treatment vs placebo), consent documentation status (paper and EMR), termination date, etc.
* Administrative Responsibilities: • Maintains proper and fair scheduling for research personnel assigned to ensure coverage is achieved. • Maintains updated records of permanent leave record forms and obtains and handles requests for vacation, sick, etc. for individuals as required to assist in research coverage. Supervises and oversees research personnel as assigned. • Tracks petty cash needed for research trials and patient reimbursements distributed. • Performs related duties to assist Directors as needed and handles details in a confidential nature Responsible for creation and management of study invoices. • Responsible for preparation and submission of ROH check requests to pay research service providers (i.e. IRB, Pharmacy) for assigned clinical trial services. Responsible for placement of requisitions for research and/or office supplies; maintains record of related orders and invoices for reimbursement. • Lead/assist with the development of study budgets for assigned clinical studies. • Responsible for the coordination and planning of site visits by study monitors and study sponsors, including planning of site visit catering services, facility and IT access needs.

Qualifications

* Graduate of an accredited nursing school/program required.
* Bachelor's Degree in nursing Preferred
* RN - Registered Nurse - State Licensure and/or Compact State Licensure in the state of Tennessee Required
* Three (3) years clinical experience as a Registered Nurse required. Two years of experience coordinating activities of clinical studies required. Experience supporting clinical studies and implementing multiple concurrent research projects preferred. Strong regulatory expertise and experience working with the IRB preferred. Microsoft Word and Excel experience required.

Physical Demands

* Standing - Occasionally
* Walking - Occasionally
* Sitting - Constantly
* Lifting - Rarely
* Carrying - Rarely
* Pushing - Rarely
* Pulling - Rarely
* Climbing - Rarely
* Balancing - Rarely
* Stooping - Rarely
* Kneeling - Rarely
* Crouching - Rarely
* Crawling - Rarely
* Reaching - Rarely
* Handling - Occasionally
* Grasping - Occasionally
* Feeling - Rarely
* Talking - Constantly
* Hearing - Constantly
* Repetitive Motions - Frequently
* Eye/Hand/Foot Coordination - Frequently

Regional One Health is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.

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