University Health Partners of Hawai'i (UCERA)
CTO Operation Supervisor and Research Nurse
University Health Partners of Hawai'i (UCERA), Honolulu, Hawaii, United States, 96814
Clinical Trials Operation Supervisor and Research Nurse
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Clinical Trials Operation Supervisor and Research Nurse
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University Health Partners of Hawai'i (UCERA) Clinical Trials Operation Supervisor and Research Nurse
3 days ago Be among the first 25 applicants Join to apply for the
Clinical Trials Operation Supervisor and Research Nurse
role at
University Health Partners of Hawai'i (UCERA) Get AI-powered advice on this job and more exclusive features. University Health Partners of Hawai'i (UCERA) provided pay range
This range is provided by University Health Partners of Hawai'i (UCERA). Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$130,000.00/yr - $130,000.00/yr Manages, serves, assists and ensures assigned clinical trial activities and clinical trial deliverables (accrual, data timeliness, query resolution, positive internal and external auditing/monitoring results, data management query resolution timelines and non- compliance reports for the development of Corrective and Preventive Action and departmental processes) are met while establishing, assigning and assessing activities of multiple teams to accomplish study goals and data management within the Clinical Trials Office (CTO). Provide oversight and training to team members who are responsible obtaining informed consent, performing protocol required study procedures, maintaining essential documentation and departmental operational policies and guidelines. Defines team deliverables and communicates staffing needs and cross-coverage of work assignments appropriately. Provides oversight, evaluates, assesses, develops and coaches ongoing workload assignments for all clinical research associates (CRA). Communicate effectively within the CTO on project findings and priorities. Assure employees in area of responsibility comply with all UHCC, regulatory and other appropriate policies and approved practices. Keeps up to date on research best practices to generate innovative solutions for clinical trial accruals and quality improvement. Creates and/or assists with standard operating procedures (SOPs), working with Center Compliance office on SOPs to meet regulatory requirements. Supports Center compliance office with Cancer Center/Consortium policies and procedures and all Federal and local regulations pertaining to human subject’s research. Assists with internal monitoring/auditing of site data as needed. Assess feasibility of research protocol, including reviewing appropriate patient population, budget and specific needs for the study. Aids in resource planning needs to accomplish study objectives. Participate in internal and external research audits and inspections. Manage project deliverables by monitoring metrics. Prepare, assist, and lead presentations of internal project status, progress of clinical trials and special projects and create progress reports to senior leadership and other stakeholders as needed.
Duties & Responsibilities (CTO Operation Supervisor):
Manages, serves, assists and ensures assigned clinical trial activities and clinical trial deliverables (accrual, data timeliness, query resolution, positive internal and external auditing/monitoring results, data management query resolution timelines and non- compliance reports for the development of Corrective and Preventive Action and departmental processes) are met while establishing, assigning and assessing activities of multiple teams to accomplish study goals and data management within the Clinical Trials Office (CTO). Provide oversight and training to team members who are responsible obtaining informed consent, performing protocol required study procedures, maintaining essential documentation and departmental operational policies and guidelines. Defines team deliverables and communicates staffing needs and cross-coverage of work assignments appropriately. Provides oversight, evaluates, assesses, develops and coaches ongoing workload assignments for all clinical research associates (CRA). Communicate effectively within the CTO on project findings and priorities. Assure employees in area of responsibility comply with all UHCC, regulatory and other appropriate policies and approved practices. Keeps up to date on research best practices to generate innovative solutions for clinical trial accruals and quality improvement. Creates and/or assists with standard operating procedures (SOPs), working with Center Compliance office on SOPs to meet regulatory requirements. Supports Center compliance office with Cancer Center/Consortium policies and procedures and all Federal and local regulations pertaining to human subject’s research. Assists with internal monitoring/auditing of site data as needed. Assess feasibility of research protocol, including reviewing appropriate patient population, budget and specific needs for the study. Aids in resource planning needs to accomplish study objectives. Participate in internal and external research audits and inspections. Manage project deliverables by monitoring metrics. Prepare, assist, and lead presentations of internal project status, progress of clinical trials and special projects and create progress reports to senior leadership and other stakeholders as needed.
Duties & Responsibilities (Clinical Trials Research Nurse):
Independently oversees education, support and conducts research using sound nursing judgement, critical thinking, and clinical knowledge and skills. Responsible for the effective and ethical conduct of oncology clinical trials. Coordinates, evaluates, and follows patients in clinical trials, which includes but is not limited to screening, identifying, enrolling and consenting patients, developing study calendars with Clinical Trial Management System team, coordinating study visits and follow-ups, and any other study-related activities. Ensures adherence to protocol requirements, and reports and documents deviations as appropriate. Performs protocol-specific clinical tasks including patient assessment, ordering tests, collecting specimens, and monitoring responses to interventions. Serves as a resource to research and clinical staff regarding protocol requirements. Reviews clinic schedules and medical records of potential clinical trials participants, matching patient characteristics with eligibility requirements of available protocols. Assists physicians and cancer care staff in coordinating laboratory tests/procedures required for pre-study testing. May dispense investigational drug under the direction of the physician, and provide patient teaching regarding administration. Maintains accurate investigational drug accountability records. Assists in collecting, processing, and preparing patient specimens for shipment as required by protocol. Assists in collecting and transmitting patient-reported information (questionnaires). Provides general clinical research, as well as study-specific information to patients and research, clinical, and other organizational staff. Serves as a resource to CRAs for any study-related issues to facilitate coordination amongst various hospital/clinic departments as required by the studies. Ensures validity of research results by ensuring timely, accurate and complete data documentation, reporting deviations, violations and serious adverse events. Responsible for all protocol data collection including completion of initial study forms, treatment forms and follow-up forms. Enters all patient tracking information into OnCore Clinical Trials Management System and/or other required data capture system in a timely manner. Reviews data for accuracy and submits data within time requirements, electronically if required. Ensures patient safety. Monitors patients for adverse events and reports according to standard guidelines or as specified in the protocol. In collaboration with the physician, reviews patients for changes in conditions, adverse events, concomitant medications use, protocol compliance, response to study drug, and thoroughly documents all findings. Monitors patients for serious adverse events per Federal and/or sponsor guidelines, within the time parameters. Develops relationships with community partners to facilitate accrual to and compliance with clinical trials. Assists in implementation of recruitment plans to identify and assess potential clinical trial participants. Identifies and develops processes to overcome barriers to clinical trial enrollment. Assists in the maintenance and distribution of clinical protocols available for patient enrollment. Provides input on new studies and study continuation. Assists in reviewing availability for industry-sponsored trials and communicating opportunities with clinical research staff and affiliated oncology practitioners. Attends UHCC clinical meetings and tumor boards at local hospitals. Completes feasibility forms and PowerPoint slides for UHCC meetings as needed. Assists in preparing for external audits and in developing corrective action plans as needed. Participates in quality assurance internal audits. Works with regulatory staff to develop patient consents. Provides in-service training on protocol requirements to clinic staff by working closely with the PI and staff to ensure that clinical procedures are completed according to protocol. This includes preparing amendments and any changes or updates in procedures and activities, which support the protocol, and disseminating all pertinent information affecting study conduct to staff throughout the duration of the study. Prepares and organizes materials for distribution to patients and clinics. Provides mentoring, education, and problem solving to research team. Advocates for clinical trials by participating in community outreach efforts to provide general clinical trials education when opportunities arise. Oversees students and/or volunteers. May mentor and train CRAs and other research support staff. Acts as the team’s lead authority for specific technical areas of clinical trials, such as training, continuing education, and quality control. Maintains working knowledge of oncology clinical care and research. Participates in education, instruction, and professional development as necessary to maintain job-related skills and competencies. Completes continuing medical education courses as deemed relevant and attends meetings and conferences as appropriate. Provides in-service training on protocol requirements to clinic staff by working closely with the PI and staff to ensure that clinical procedures are completed according to protocol. Complies with all legal requirements and company policies. Maintains patient confidentiality at all times. Performs all other duties as assigned.
QUALIFICATION REQUIREMENTS
Education/Training/
Experience
Minimum:
Bachelor’s Degree from an accredited four (4) year college or university in Nursing. (Associate’s Degree from an accredited community college in Nursing with at least two (2) years of professional experience in health sector may substitute for a Bachelor’s Degree.) Must possess a State of Hawai‘i RN license Must complete Collaborative Institutional Training Initiative (CITI) Human Subject training within three (3) months from date of hire. Current BLS CPR Certification Four years of experience as a Registered Nurse (RN) in a related clinical specialty (e.g., oncology) or clinical trials experience in oncology.
Preferred:
Master’s Degree from an accredited college or university in Nursing. Oncology Certified Nurse (OCN), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP). Experience in IV access placement, venous access devices, oncology medication administration and monitoring including oral therapies, injections and infusions.
Minimum:
Skills Knowledge
Demonstrated knowledge in human subjects’ research and International Conference on Harmonization (ICH) Demonstrated knowledge in Good Clinical Practices (GCP) Demonstrated knowledge in Health Insurance Portability and Accountability Act (HIPAA) training. Understanding of research study designs and ethics. Knowledge of and experience with computers and software programs, including word-processing, spreadsheets, and database. Specialized knowledge of clinical trial protocols grouped from a specific National Cancer Institute (NCI) research base, other source, or by disease site, etc. Specialized knowledge of specific cancer care sites conducting clinical trials or of job areas, such as education/training, regulatory, investigational drug accountability/storage, specimen collection/processing, database maintenance/reporting, and auditing. Strong and effective written and verbal communication skills.
Preferred:
Working knowledge of the University of Hawai‘i and UHCC policies and procedures.
BENEFITS
Generous time off benefits 100% employee health and dental coverage and vision Flexible spending plan Retirement plan with up to 3% dollar-for-dollar company matching contributions 100% company paid group Life/AD&D/LTD insurance Employee assistance program (EAP) Pet Insurance, Prepaid legal with competitive rates
UHP Hawai‘i is an EEO/AAP employer. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
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Join to apply for the
Clinical Trials Operation Supervisor and Research Nurse
role at
University Health Partners of Hawai'i (UCERA) Clinical Trials Operation Supervisor and Research Nurse
3 days ago Be among the first 25 applicants Join to apply for the
Clinical Trials Operation Supervisor and Research Nurse
role at
University Health Partners of Hawai'i (UCERA) Get AI-powered advice on this job and more exclusive features. University Health Partners of Hawai'i (UCERA) provided pay range
This range is provided by University Health Partners of Hawai'i (UCERA). Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$130,000.00/yr - $130,000.00/yr Manages, serves, assists and ensures assigned clinical trial activities and clinical trial deliverables (accrual, data timeliness, query resolution, positive internal and external auditing/monitoring results, data management query resolution timelines and non- compliance reports for the development of Corrective and Preventive Action and departmental processes) are met while establishing, assigning and assessing activities of multiple teams to accomplish study goals and data management within the Clinical Trials Office (CTO). Provide oversight and training to team members who are responsible obtaining informed consent, performing protocol required study procedures, maintaining essential documentation and departmental operational policies and guidelines. Defines team deliverables and communicates staffing needs and cross-coverage of work assignments appropriately. Provides oversight, evaluates, assesses, develops and coaches ongoing workload assignments for all clinical research associates (CRA). Communicate effectively within the CTO on project findings and priorities. Assure employees in area of responsibility comply with all UHCC, regulatory and other appropriate policies and approved practices. Keeps up to date on research best practices to generate innovative solutions for clinical trial accruals and quality improvement. Creates and/or assists with standard operating procedures (SOPs), working with Center Compliance office on SOPs to meet regulatory requirements. Supports Center compliance office with Cancer Center/Consortium policies and procedures and all Federal and local regulations pertaining to human subject’s research. Assists with internal monitoring/auditing of site data as needed. Assess feasibility of research protocol, including reviewing appropriate patient population, budget and specific needs for the study. Aids in resource planning needs to accomplish study objectives. Participate in internal and external research audits and inspections. Manage project deliverables by monitoring metrics. Prepare, assist, and lead presentations of internal project status, progress of clinical trials and special projects and create progress reports to senior leadership and other stakeholders as needed.
Duties & Responsibilities (CTO Operation Supervisor):
Manages, serves, assists and ensures assigned clinical trial activities and clinical trial deliverables (accrual, data timeliness, query resolution, positive internal and external auditing/monitoring results, data management query resolution timelines and non- compliance reports for the development of Corrective and Preventive Action and departmental processes) are met while establishing, assigning and assessing activities of multiple teams to accomplish study goals and data management within the Clinical Trials Office (CTO). Provide oversight and training to team members who are responsible obtaining informed consent, performing protocol required study procedures, maintaining essential documentation and departmental operational policies and guidelines. Defines team deliverables and communicates staffing needs and cross-coverage of work assignments appropriately. Provides oversight, evaluates, assesses, develops and coaches ongoing workload assignments for all clinical research associates (CRA). Communicate effectively within the CTO on project findings and priorities. Assure employees in area of responsibility comply with all UHCC, regulatory and other appropriate policies and approved practices. Keeps up to date on research best practices to generate innovative solutions for clinical trial accruals and quality improvement. Creates and/or assists with standard operating procedures (SOPs), working with Center Compliance office on SOPs to meet regulatory requirements. Supports Center compliance office with Cancer Center/Consortium policies and procedures and all Federal and local regulations pertaining to human subject’s research. Assists with internal monitoring/auditing of site data as needed. Assess feasibility of research protocol, including reviewing appropriate patient population, budget and specific needs for the study. Aids in resource planning needs to accomplish study objectives. Participate in internal and external research audits and inspections. Manage project deliverables by monitoring metrics. Prepare, assist, and lead presentations of internal project status, progress of clinical trials and special projects and create progress reports to senior leadership and other stakeholders as needed.
Duties & Responsibilities (Clinical Trials Research Nurse):
Independently oversees education, support and conducts research using sound nursing judgement, critical thinking, and clinical knowledge and skills. Responsible for the effective and ethical conduct of oncology clinical trials. Coordinates, evaluates, and follows patients in clinical trials, which includes but is not limited to screening, identifying, enrolling and consenting patients, developing study calendars with Clinical Trial Management System team, coordinating study visits and follow-ups, and any other study-related activities. Ensures adherence to protocol requirements, and reports and documents deviations as appropriate. Performs protocol-specific clinical tasks including patient assessment, ordering tests, collecting specimens, and monitoring responses to interventions. Serves as a resource to research and clinical staff regarding protocol requirements. Reviews clinic schedules and medical records of potential clinical trials participants, matching patient characteristics with eligibility requirements of available protocols. Assists physicians and cancer care staff in coordinating laboratory tests/procedures required for pre-study testing. May dispense investigational drug under the direction of the physician, and provide patient teaching regarding administration. Maintains accurate investigational drug accountability records. Assists in collecting, processing, and preparing patient specimens for shipment as required by protocol. Assists in collecting and transmitting patient-reported information (questionnaires). Provides general clinical research, as well as study-specific information to patients and research, clinical, and other organizational staff. Serves as a resource to CRAs for any study-related issues to facilitate coordination amongst various hospital/clinic departments as required by the studies. Ensures validity of research results by ensuring timely, accurate and complete data documentation, reporting deviations, violations and serious adverse events. Responsible for all protocol data collection including completion of initial study forms, treatment forms and follow-up forms. Enters all patient tracking information into OnCore Clinical Trials Management System and/or other required data capture system in a timely manner. Reviews data for accuracy and submits data within time requirements, electronically if required. Ensures patient safety. Monitors patients for adverse events and reports according to standard guidelines or as specified in the protocol. In collaboration with the physician, reviews patients for changes in conditions, adverse events, concomitant medications use, protocol compliance, response to study drug, and thoroughly documents all findings. Monitors patients for serious adverse events per Federal and/or sponsor guidelines, within the time parameters. Develops relationships with community partners to facilitate accrual to and compliance with clinical trials. Assists in implementation of recruitment plans to identify and assess potential clinical trial participants. Identifies and develops processes to overcome barriers to clinical trial enrollment. Assists in the maintenance and distribution of clinical protocols available for patient enrollment. Provides input on new studies and study continuation. Assists in reviewing availability for industry-sponsored trials and communicating opportunities with clinical research staff and affiliated oncology practitioners. Attends UHCC clinical meetings and tumor boards at local hospitals. Completes feasibility forms and PowerPoint slides for UHCC meetings as needed. Assists in preparing for external audits and in developing corrective action plans as needed. Participates in quality assurance internal audits. Works with regulatory staff to develop patient consents. Provides in-service training on protocol requirements to clinic staff by working closely with the PI and staff to ensure that clinical procedures are completed according to protocol. This includes preparing amendments and any changes or updates in procedures and activities, which support the protocol, and disseminating all pertinent information affecting study conduct to staff throughout the duration of the study. Prepares and organizes materials for distribution to patients and clinics. Provides mentoring, education, and problem solving to research team. Advocates for clinical trials by participating in community outreach efforts to provide general clinical trials education when opportunities arise. Oversees students and/or volunteers. May mentor and train CRAs and other research support staff. Acts as the team’s lead authority for specific technical areas of clinical trials, such as training, continuing education, and quality control. Maintains working knowledge of oncology clinical care and research. Participates in education, instruction, and professional development as necessary to maintain job-related skills and competencies. Completes continuing medical education courses as deemed relevant and attends meetings and conferences as appropriate. Provides in-service training on protocol requirements to clinic staff by working closely with the PI and staff to ensure that clinical procedures are completed according to protocol. Complies with all legal requirements and company policies. Maintains patient confidentiality at all times. Performs all other duties as assigned.
QUALIFICATION REQUIREMENTS
Education/Training/
Experience
Minimum:
Bachelor’s Degree from an accredited four (4) year college or university in Nursing. (Associate’s Degree from an accredited community college in Nursing with at least two (2) years of professional experience in health sector may substitute for a Bachelor’s Degree.) Must possess a State of Hawai‘i RN license Must complete Collaborative Institutional Training Initiative (CITI) Human Subject training within three (3) months from date of hire. Current BLS CPR Certification Four years of experience as a Registered Nurse (RN) in a related clinical specialty (e.g., oncology) or clinical trials experience in oncology.
Preferred:
Master’s Degree from an accredited college or university in Nursing. Oncology Certified Nurse (OCN), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP). Experience in IV access placement, venous access devices, oncology medication administration and monitoring including oral therapies, injections and infusions.
Minimum:
Skills Knowledge
Demonstrated knowledge in human subjects’ research and International Conference on Harmonization (ICH) Demonstrated knowledge in Good Clinical Practices (GCP) Demonstrated knowledge in Health Insurance Portability and Accountability Act (HIPAA) training. Understanding of research study designs and ethics. Knowledge of and experience with computers and software programs, including word-processing, spreadsheets, and database. Specialized knowledge of clinical trial protocols grouped from a specific National Cancer Institute (NCI) research base, other source, or by disease site, etc. Specialized knowledge of specific cancer care sites conducting clinical trials or of job areas, such as education/training, regulatory, investigational drug accountability/storage, specimen collection/processing, database maintenance/reporting, and auditing. Strong and effective written and verbal communication skills.
Preferred:
Working knowledge of the University of Hawai‘i and UHCC policies and procedures.
BENEFITS
Generous time off benefits 100% employee health and dental coverage and vision Flexible spending plan Retirement plan with up to 3% dollar-for-dollar company matching contributions 100% company paid group Life/AD&D/LTD insurance Employee assistance program (EAP) Pet Insurance, Prepaid legal with competitive rates
UHP Hawai‘i is an EEO/AAP employer. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Management and Manufacturing Industries Medical Practices Referrals increase your chances of interviewing at University Health Partners of Hawai'i (UCERA) by 2x Get notified about new Operations Supervisor jobs in
Honolulu, HI . Administrative Services Assistant - Executive Office on Early Learning
Honolulu, HI $5,369.00-$6,535.00 1 month ago (USA) Manager, Facilities Maintenance Operations - License
Operations Manager, JB Pearl Harbor-Hickam
Hickam Village, HI $121,680.00-$140,300.00 3 days ago Assistant Operations Manager - Food & Beverage
Kapolei, HI $95,000.00-$120,000.00 23 hours ago Medical Technologist, Pathology, Hematology, On-call, Variable Shifts
Waipi'o, HI $55,000.00-$60,000.00 2 weeks ago Operations Leader & Project Manager (Federal)
Court Operations Specialist V (HR - Employee Development) - Honolulu, Oahu
Food Service - Assistant Operations Manager at the USS Bowfin
ASSISTANT FIELD OPERATIONS MANAGER (ASSISTANT PROGRAM ADMINISTRATOR) (EM-07) [1 vacancy]
Pearl City, HI $95,000.00-$120,000.00 23 hours ago ADMINISTRATIVE SERVICES ASSISTANT - OAHU
Joint Base Pearl Harbor-Hickam, HI 1 day ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr