Virginia Mason Franciscan Health
Research Coordinator Institute RN
Virginia Mason Franciscan Health, Tacoma, Washington, us, 98417
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Job Summary and Responsibilities Conduct professional nursing research and study services (in a variety of inpatient and/or outpatient settings) in support of specified pharmaceutical or medical device research programs, and for ensuring that all clinical activities are carried out in accordance with the established protocol and within acceptable clinical procedural and safety standards. Work includes planning and executing procedures for screening, enrolling, monitoring and retaining clinical research patients and/or volunteers in accordance with established study protocol(s) and FDA (Federal Drug Administration) guidelines for clinical trials, research study management and monitoring.
Essential Functions Include
Determine patient eligibility for participation in drug and/or medical device research studies/protocols, ensuring the rights, safety and welfare of patients at all times.
Screen patients in a timely and accurate manner using protocol‑specific inclusion and exclusion criteria.
Explain the purpose, risks and benefits of clinical trial participation.
Ensure that study patients understand the information presented and agree to the conditions; obtain a signed consent form prior to any study‑related procedure being performed.
Provide instructions to patients to ensure proper protocol compliance.
Analyze established protocol(s) guidelines to understand, interpret and implement provisions, assessments and requirements and to ensure that proper protocol procedures and medication administration are followed and executed accordingly.
Plan, schedule and document day‑to‑day clinical activities and procedures, ensuring efficient workflow and adequate care and treatment of research patients; coordinate and monitor the collection, processing and recording of clinical data and/or specimen samples, as required by the study protocol.
Perform EKG and phlebotomy; monitor vital signs and/or perform other specialized nursing procedures as appropriate to the specific requirements of the study and the needs of the individual patients; may administer prescribed study medications, assess IVs and/or conduct patient physicals if allowed under the study protocol.
Schedule, conduct and document follow‑up visits (in person or via telephone) as outlined in the study protocol; coordinate follow‑up visits to correspond to other scheduled appointments to facilitate patient convenience; follow up with patients between scheduled visits to identify side effects, medical events or hospitalizations, and advise Investigator, sponsor and MREC as necessary.
Provide subject care according to protocol and in accordance with established regulations and guidelines (i.e. FDA, GCP/ICH).
Perform, or make arrangements for, all study procedures and assessments.
Work with Research pharmacy staff to ensure proper preparation, timing and administration of study medication.
Participate in budget administration and feasibility assessments with respect to new/current clinical trials; assist management in goal setting and formulation/implementation of action plans for the Research department.
Work collaboratively with study sponsors (drug companies), and prepare/provide accurate, timely and complete documentation.
Act as liaison to ensure complete and accurate communication between sponsor, investigators and other research staff and patients.
Create appropriate source documents or use sponsor‑provided source documents; obtain protocol‑specific data to complete and maintain source document(s) and case report form(s) (CRF) in accordance with applicable regulations, guidelines and sponsor requirements.
Monitor and record patient response to treatment, and communicate study data and results to investigators; maintain complete source documentation and oversee the preparation of study activity reports for sponsors and various medical, legal and regulatory bodies as appropriate.
Provide FHS MREC with timely, accurate and complete information in accordance with established procedures, FDA regulations and GCP guidelines; identify and notify MREC of adverse events and protocol deviations; submit annual reports for each assigned protocol on a timely basis.
Serve as point‑person for routine monitoring visits and external audits of assigned studies as conducted by sponsors, the FDA and/or other entities.
Meet with auditors, clarify and research information, review findings and take corrective action as necessary.
Participate in department operations to include coordinating protocol‑specific meetings, communications and needed services for other FHS departments.
Coordinate protocol‑specific intra‑ and inter‑departmental scheduling and communication activities.
Schedule site initiation meetings with management.
Provide in‑service education on protocols to physicians’ offices, Research Center staff and/or other departments.
Coordinate assistance needed from other FHS departments (i.e. Patient Care areas, Laboratory, Business Office).
Cultural Sensitivity and Competence: Demonstrate proper use of communication tools/materials for effective communication and understand how the culture(s) of patient populations can affect communication, collaboration and the provision of care, treatment and services. Patient Population Served: Demonstrate knowledge and proper skills associated with the department’s defined specific populations served.
Employees may be required to perform other duties as assigned.
Job Requirements Education / Experience:
Associate's degree in Nursing
3+ years of recent closely related work experience that demonstrates the attainment of the requisite job knowledge, skills and abilities.
Certifications
Active Washington State Registered Nurse License
Basic Life Support - CPR (BLS-CPR)
Where You'll Work Virginia Mason Franciscan Health has a rich history of providing exceptional healthcare, dating back to 1891. Building upon a legacy of compassionate care and innovation, our organization has evolved through strategic partnerships and integrations to expand our reach and services across the Puget Sound area. Today, as Virginia Mason Franciscan Health, we remain deeply committed to healing the whole person – body, mind, and spirit – in the communities we serve. This commitment is strengthened by the diverse expertise and shared values brought together through our growth. Our dedicated providers offer a full spectrum of health care services, from routine wellness to complex disease management, all grounded in rigorous research and education. Our comprehensive network of 10 hospitals and nearly 300 care sites strategically located across the greater Puget Sound region reflects our ongoing commitment to accessibility and comprehensive care. We are proud of our pioneering medical advances and numerous awards and accreditations that reflect our dedication to excellence. When you join Virginia Mason Franciscan Health, you become part of a team that delivers top-quality, professional healthcare in modern, well‑equipped facilities, and contributes to a legacy of service built on collaboration and shared purpose.
Pay Range $45.26 - $67.32 /hour
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Job Summary and Responsibilities Conduct professional nursing research and study services (in a variety of inpatient and/or outpatient settings) in support of specified pharmaceutical or medical device research programs, and for ensuring that all clinical activities are carried out in accordance with the established protocol and within acceptable clinical procedural and safety standards. Work includes planning and executing procedures for screening, enrolling, monitoring and retaining clinical research patients and/or volunteers in accordance with established study protocol(s) and FDA (Federal Drug Administration) guidelines for clinical trials, research study management and monitoring.
Essential Functions Include
Determine patient eligibility for participation in drug and/or medical device research studies/protocols, ensuring the rights, safety and welfare of patients at all times.
Screen patients in a timely and accurate manner using protocol‑specific inclusion and exclusion criteria.
Explain the purpose, risks and benefits of clinical trial participation.
Ensure that study patients understand the information presented and agree to the conditions; obtain a signed consent form prior to any study‑related procedure being performed.
Provide instructions to patients to ensure proper protocol compliance.
Analyze established protocol(s) guidelines to understand, interpret and implement provisions, assessments and requirements and to ensure that proper protocol procedures and medication administration are followed and executed accordingly.
Plan, schedule and document day‑to‑day clinical activities and procedures, ensuring efficient workflow and adequate care and treatment of research patients; coordinate and monitor the collection, processing and recording of clinical data and/or specimen samples, as required by the study protocol.
Perform EKG and phlebotomy; monitor vital signs and/or perform other specialized nursing procedures as appropriate to the specific requirements of the study and the needs of the individual patients; may administer prescribed study medications, assess IVs and/or conduct patient physicals if allowed under the study protocol.
Schedule, conduct and document follow‑up visits (in person or via telephone) as outlined in the study protocol; coordinate follow‑up visits to correspond to other scheduled appointments to facilitate patient convenience; follow up with patients between scheduled visits to identify side effects, medical events or hospitalizations, and advise Investigator, sponsor and MREC as necessary.
Provide subject care according to protocol and in accordance with established regulations and guidelines (i.e. FDA, GCP/ICH).
Perform, or make arrangements for, all study procedures and assessments.
Work with Research pharmacy staff to ensure proper preparation, timing and administration of study medication.
Participate in budget administration and feasibility assessments with respect to new/current clinical trials; assist management in goal setting and formulation/implementation of action plans for the Research department.
Work collaboratively with study sponsors (drug companies), and prepare/provide accurate, timely and complete documentation.
Act as liaison to ensure complete and accurate communication between sponsor, investigators and other research staff and patients.
Create appropriate source documents or use sponsor‑provided source documents; obtain protocol‑specific data to complete and maintain source document(s) and case report form(s) (CRF) in accordance with applicable regulations, guidelines and sponsor requirements.
Monitor and record patient response to treatment, and communicate study data and results to investigators; maintain complete source documentation and oversee the preparation of study activity reports for sponsors and various medical, legal and regulatory bodies as appropriate.
Provide FHS MREC with timely, accurate and complete information in accordance with established procedures, FDA regulations and GCP guidelines; identify and notify MREC of adverse events and protocol deviations; submit annual reports for each assigned protocol on a timely basis.
Serve as point‑person for routine monitoring visits and external audits of assigned studies as conducted by sponsors, the FDA and/or other entities.
Meet with auditors, clarify and research information, review findings and take corrective action as necessary.
Participate in department operations to include coordinating protocol‑specific meetings, communications and needed services for other FHS departments.
Coordinate protocol‑specific intra‑ and inter‑departmental scheduling and communication activities.
Schedule site initiation meetings with management.
Provide in‑service education on protocols to physicians’ offices, Research Center staff and/or other departments.
Coordinate assistance needed from other FHS departments (i.e. Patient Care areas, Laboratory, Business Office).
Cultural Sensitivity and Competence: Demonstrate proper use of communication tools/materials for effective communication and understand how the culture(s) of patient populations can affect communication, collaboration and the provision of care, treatment and services. Patient Population Served: Demonstrate knowledge and proper skills associated with the department’s defined specific populations served.
Employees may be required to perform other duties as assigned.
Job Requirements Education / Experience:
Associate's degree in Nursing
3+ years of recent closely related work experience that demonstrates the attainment of the requisite job knowledge, skills and abilities.
Certifications
Active Washington State Registered Nurse License
Basic Life Support - CPR (BLS-CPR)
Where You'll Work Virginia Mason Franciscan Health has a rich history of providing exceptional healthcare, dating back to 1891. Building upon a legacy of compassionate care and innovation, our organization has evolved through strategic partnerships and integrations to expand our reach and services across the Puget Sound area. Today, as Virginia Mason Franciscan Health, we remain deeply committed to healing the whole person – body, mind, and spirit – in the communities we serve. This commitment is strengthened by the diverse expertise and shared values brought together through our growth. Our dedicated providers offer a full spectrum of health care services, from routine wellness to complex disease management, all grounded in rigorous research and education. Our comprehensive network of 10 hospitals and nearly 300 care sites strategically located across the greater Puget Sound region reflects our ongoing commitment to accessibility and comprehensive care. We are proud of our pioneering medical advances and numerous awards and accreditations that reflect our dedication to excellence. When you join Virginia Mason Franciscan Health, you become part of a team that delivers top-quality, professional healthcare in modern, well‑equipped facilities, and contributes to a legacy of service built on collaboration and shared purpose.
Pay Range $45.26 - $67.32 /hour
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