University of Hawaii John A. Burns School of Medicine
HICFA Research Coordinator (Nursing)
University of Hawaii John A. Burns School of Medicine, Honolulu, Hawaii, United States, 96814
Overview
Join to apply for the
HICFA Research Coordinator (Nursing)
role at
University of Hawaii John A. Burns School of Medicine . This is a Regular, Full-Time, RCUH Non-Civil Service position with the University of Hawaii (UH), John A. Burns School of Medicine (JABSOM), Hawaii Center for AIDS (HICFA), located in Honolulu, Hawaii. Continuation of employment is dependent upon program/operational needs, satisfactory work performance, availability of funds, and compliance with applicable Federal/State laws. Summary of Duties
Coordinates and administers clinical trial/research studies from study start-up to conduct of the trial to study closure. Assists with critically evaluating each protocol for regulatory compliance, patient safety, resource utilization and feasibility. Works with the Principal Investigator (PI) and programmatic staff to decide whether to participate in the study. Assists with study budgets as needed. Participates in study meetings and conference calls. Assists HICFA Program Manager and Unit Coordinator with start-up activities, providing needed information to open the study. Ensures site compliance with research protocols. Ensures the appropriate implementation and documentation of all protocol-mandated visits and procedures. Ensures assigned studies are conducted in accordance with FDA, OHRP, and Good Clinical Practices (GCP) guidelines. Interacts with research and regulatory officials at collaborating institutions to ensure successful implementation of each assigned study. Uses electronic medical record (EMR) as needed. Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine eligibility. Employs strategies to maintain recruitment and retention. Provides patient education and explains informed consent documents to participants to ensure full understanding of protocol requirements and the risks and benefits of participation. Develops accurate source materials. Provides accurate and timely data collection and documentation. Conducts research study visits and performs medical tests (e.g., phlebotomy, vital signs, ECGs) as required by the specific protocol. Provides referral oversight for testing at other clinical facilities. Coordinates the management of investigational products (IP) with the study pharmacist. Under the direction of the PI and per research protocols, administers the investigational medications and performs participant assessments for different research protocols. Determines adverse event grades. Follows protocol-mandated procedures for notification of the PI or designee. Files mandated reports as required by protocol. Performs and participates in quality control and assurance of research data. Available to study participants during work hours to address concerns. Ensures any potential issues are conveyed to the on-call physician. Prepares for study monitoring visits and meets with the study monitor as needed. Handles or supervises database entry for the study. Major Duties & Responsibilities
Coordinates and administers clinical trial/research studies from start-up to study closure: assists with evaluating protocols for regulatory compliance, patient safety, resource utilization and feasibility; works with the PI and program staff to decide to participate in the study; assists with study budgets; participates in study meetings; supports start-up activities and ensures site compliance with research protocols. Ensures the appropriate implementation and documentation of all protocol-mandated visits and procedures. Ensures studies are conducted in accordance with FDA, OHRP, and GCP guidelines. Interacts with collaborating institutions to ensure successful implementation. Uses EMR as needed. Participates in recruitment on and off campus and selection of study participants, documenting medical history to determine eligibility; maintains recruitment and retention. Provides patient education and informed consent explanations. Develops accurate source materials. Provides data collection and documentation. Conducts study visits on and off campus and performs medical tests as required by the protocol. Provides referral oversight for testing at other clinical facilities. Coordinates IP management with the study pharmacist. Under the direction of the PI and per protocol, administers investigational medications and performs participant assessments. Determines adverse event grades and notifies PI or designee. Files mandated reports. Performs quality control and assurance of data. Available to study participants during work hours to address concerns. Prepares for monitoring visits and meets with monitors. Handles or supervises database entry for the study. Drives to worksite meetings. Performs other duties as assigned. Primary Qualifications
Education Bachelors Degree from an accredited four-year college or university in Nursing or related field. Knowledge Working knowledge of clinical trial or research regulatory and procedural ethics and requirements. Abilities & Skills Excellent verbal and written communication skills in English. Ability to perform phlebotomy and physical exams. Excellent interpersonal communication and problem-solving skills. Ability to multi-task, medically triage, work independently and well with others. Ability to be non-judgmental and flexible. Meticulous attention to detail in review of patient records and case report forms. Proficient with Microsoft Word and Excel and familiar with electronic medical records. Must possess a valid drivers license and, if using a personal vehicle for work, must maintain valid personal auto insurance equivalent to Hawaiis No-Fault Drivers Insurance. Post Offer/Employment Condition Must be able to pass a post-offer criminal background check. Must complete UH Title IX training within twelve (12) months from date of hire. Must complete UH Information Security Awareness Training (ISAT) within two (2) weeks from date of hire, and recertify every twelve (12) months. Physical/Medical Demands
Ability to lift and carry up to twenty-five (25) pounds unassisted. Policy/Regulatory Requirements
As a condition of employment, employee will be subject to all applicable RCUH policies, procedures, and trainings and, as applicable, subject to the University of Hawaii's HIPAA/PHI privacy and security policy. Violation of the RCUH's, the UH's, or the business entity's policies and/or procedures or applicable State or Federal laws and/or regulations may lead to disciplinary action (including, but not limited to possible termination of employment, personal fines, civil and/or criminal penalties, etc.). Must complete the University of Hawaii's Hawaii Center for AIDS (HICFA) HIPAA/PHI privacy and security training immediately after hire or not later than employees initial exposure to HIPAA/PHI. Must maintain a current status on the Universitys and/or the business entity's training requirements. Secondary Qualifications
Master's Degree from an accredited college or university in Nursing. Experience working with individuals living with HIV and their health issues. Experience in clinical trials work. Experience in a clinical or translational research setting, or an equivalent combination of experience and training which provides knowledge, abilities, and skills to perform the job. IV insertion skills. Seniority level Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Higher Education
#J-18808-Ljbffr
Join to apply for the
HICFA Research Coordinator (Nursing)
role at
University of Hawaii John A. Burns School of Medicine . This is a Regular, Full-Time, RCUH Non-Civil Service position with the University of Hawaii (UH), John A. Burns School of Medicine (JABSOM), Hawaii Center for AIDS (HICFA), located in Honolulu, Hawaii. Continuation of employment is dependent upon program/operational needs, satisfactory work performance, availability of funds, and compliance with applicable Federal/State laws. Summary of Duties
Coordinates and administers clinical trial/research studies from study start-up to conduct of the trial to study closure. Assists with critically evaluating each protocol for regulatory compliance, patient safety, resource utilization and feasibility. Works with the Principal Investigator (PI) and programmatic staff to decide whether to participate in the study. Assists with study budgets as needed. Participates in study meetings and conference calls. Assists HICFA Program Manager and Unit Coordinator with start-up activities, providing needed information to open the study. Ensures site compliance with research protocols. Ensures the appropriate implementation and documentation of all protocol-mandated visits and procedures. Ensures assigned studies are conducted in accordance with FDA, OHRP, and Good Clinical Practices (GCP) guidelines. Interacts with research and regulatory officials at collaborating institutions to ensure successful implementation of each assigned study. Uses electronic medical record (EMR) as needed. Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine eligibility. Employs strategies to maintain recruitment and retention. Provides patient education and explains informed consent documents to participants to ensure full understanding of protocol requirements and the risks and benefits of participation. Develops accurate source materials. Provides accurate and timely data collection and documentation. Conducts research study visits and performs medical tests (e.g., phlebotomy, vital signs, ECGs) as required by the specific protocol. Provides referral oversight for testing at other clinical facilities. Coordinates the management of investigational products (IP) with the study pharmacist. Under the direction of the PI and per research protocols, administers the investigational medications and performs participant assessments for different research protocols. Determines adverse event grades. Follows protocol-mandated procedures for notification of the PI or designee. Files mandated reports as required by protocol. Performs and participates in quality control and assurance of research data. Available to study participants during work hours to address concerns. Ensures any potential issues are conveyed to the on-call physician. Prepares for study monitoring visits and meets with the study monitor as needed. Handles or supervises database entry for the study. Major Duties & Responsibilities
Coordinates and administers clinical trial/research studies from start-up to study closure: assists with evaluating protocols for regulatory compliance, patient safety, resource utilization and feasibility; works with the PI and program staff to decide to participate in the study; assists with study budgets; participates in study meetings; supports start-up activities and ensures site compliance with research protocols. Ensures the appropriate implementation and documentation of all protocol-mandated visits and procedures. Ensures studies are conducted in accordance with FDA, OHRP, and GCP guidelines. Interacts with collaborating institutions to ensure successful implementation. Uses EMR as needed. Participates in recruitment on and off campus and selection of study participants, documenting medical history to determine eligibility; maintains recruitment and retention. Provides patient education and informed consent explanations. Develops accurate source materials. Provides data collection and documentation. Conducts study visits on and off campus and performs medical tests as required by the protocol. Provides referral oversight for testing at other clinical facilities. Coordinates IP management with the study pharmacist. Under the direction of the PI and per protocol, administers investigational medications and performs participant assessments. Determines adverse event grades and notifies PI or designee. Files mandated reports. Performs quality control and assurance of data. Available to study participants during work hours to address concerns. Prepares for monitoring visits and meets with monitors. Handles or supervises database entry for the study. Drives to worksite meetings. Performs other duties as assigned. Primary Qualifications
Education Bachelors Degree from an accredited four-year college or university in Nursing or related field. Knowledge Working knowledge of clinical trial or research regulatory and procedural ethics and requirements. Abilities & Skills Excellent verbal and written communication skills in English. Ability to perform phlebotomy and physical exams. Excellent interpersonal communication and problem-solving skills. Ability to multi-task, medically triage, work independently and well with others. Ability to be non-judgmental and flexible. Meticulous attention to detail in review of patient records and case report forms. Proficient with Microsoft Word and Excel and familiar with electronic medical records. Must possess a valid drivers license and, if using a personal vehicle for work, must maintain valid personal auto insurance equivalent to Hawaiis No-Fault Drivers Insurance. Post Offer/Employment Condition Must be able to pass a post-offer criminal background check. Must complete UH Title IX training within twelve (12) months from date of hire. Must complete UH Information Security Awareness Training (ISAT) within two (2) weeks from date of hire, and recertify every twelve (12) months. Physical/Medical Demands
Ability to lift and carry up to twenty-five (25) pounds unassisted. Policy/Regulatory Requirements
As a condition of employment, employee will be subject to all applicable RCUH policies, procedures, and trainings and, as applicable, subject to the University of Hawaii's HIPAA/PHI privacy and security policy. Violation of the RCUH's, the UH's, or the business entity's policies and/or procedures or applicable State or Federal laws and/or regulations may lead to disciplinary action (including, but not limited to possible termination of employment, personal fines, civil and/or criminal penalties, etc.). Must complete the University of Hawaii's Hawaii Center for AIDS (HICFA) HIPAA/PHI privacy and security training immediately after hire or not later than employees initial exposure to HIPAA/PHI. Must maintain a current status on the Universitys and/or the business entity's training requirements. Secondary Qualifications
Master's Degree from an accredited college or university in Nursing. Experience working with individuals living with HIV and their health issues. Experience in clinical trials work. Experience in a clinical or translational research setting, or an equivalent combination of experience and training which provides knowledge, abilities, and skills to perform the job. IV insertion skills. Seniority level Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Higher Education
#J-18808-Ljbffr