Job Description:
Clinical Research Assistant
Digestive Disease Institute
Seattle, WA
Full-time, 40 hours/week
Monday - Friday, 8 am - 5 pm
The hourly salary range for this position starts at $17/98/hour and increases with years of relevant work experience.
Located in Seattle, WA, Virginia Mason Medical Center is an internationally recognized leader in the continuous improvement of health care. With an extensive list of awards and distinctions that includes our recognition as [insert award], Virginia Mason offers you the opportunity to partner with exceptionally talented peers at every level.
You will contribute to the strength of our Team Medicine approach to collaborative medicine and benefit from the changes enacted through our Virginia Mason Production System—a model that has transformed health care by providing patients with easier access to care, reducing errors, and continuously innovating patient safety and quality that has been adopted by other organizations here and abroad. Join us, and find out how many ways Virginia Mason offers you the chance to focus on what really matters—our patients.
The Clinical Research Assistant supports the operations of federally- and/or commercially-funded clinical, biomedical and/or behavioral research studies involving human subjects under direct supervision.
Applies the research protocol for a limited number of studies under direct supervision. With the research coordinator, helps pre-screen potential subjects and help determine eligibility according to the study protocol. Maintains subject enrollment logs for research study.
Attends research-related meetings (e.g., site initiation meetings, monitor visits). Communicates as directed with sponsor and team. Completes sponsor-required duties in preparation for study monitor visits.
Completes and submits documents for IRB review under direct supervision by clinical research coordinator and/or manager. Completes and submits appropriate Institutional Review Board (IRB) documents and receives approval prior to enrolling subjects; corresponds with the IRB on safety reporting and study modifications, closure to accrual reports, and annual reviews; and maintains regulatory files/binders. Submits closure report to IRB when all visits are completed and adverse events have been resolved; ensures that study documentation is accounted for, organized and archived.
Fulfills subject care requirements including but not limited to: appointment scheduling, helping to plan for subject visits by preparing/reviewing charts and laboratory kits, arriving, performing vital signs, subject health assessment, follow-up scheduling, and upholding protocol compliance and subject safety. Maintains subject and document confidentiality at all times.
Performs phlebotomy and specimen (blood/stool/urine/biopsy) processing/routing using universal precautions. Handles dry ice and ships specimens according to protocols daily.
Provides appropriate study-related education and updates to the applicable clinical staff in a timely manner.
Maintains current, accurate documentation including subject information, to research coordinator/PI as appropriate. Provides subject-specific reports for investigator review and signature. Transcribes data from source documents to case report forms.
Distributes, inventories, accounts for and returns clinical study medication/devices, lab kits, etc. per FDA regulations and Good Clinical Practices (GCPs) for handling clinical study materials.
Understands and complies with all applicable sponsor requirements and regulations, including the Food and Drug Administration (FDA), GCPs, International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), and established institutional policies and procedures.
Writes scripts while using Electronic Medical Record system used at Virginia Mason. Handles test article and helps facilitate study drug accountability. Completes routine data entry for a variety of studies and maintains study enrollment logs.
Associate's degree or equivalent required. At least one year experience in some healthcare setting. Skill in using word processing and spreadsheet software. Ability to prioritize and implement simultaneous research projects while working under general supervision. Strong organizational skills and aptitude for detail. Knowledge of research guidelines and regulatory requirements established by such federal and state agencies as the FDA, National Institutes of Health (NIH), Benaroya Research Institute (BRI) at VMMC and database collection. CPR certification required; Healthcare Assistant Certification may be required based on position responsibilities (e.g., performing phlebotomy). Completion of: 1) Human Subjects Research Training tutorial and classes; 2) Ethical Human Research training; and 3) shipping and handling of hazardous materials training provided by BRI required within 30 days of hire.
Able to stand and walk for up to five hours a day. Able to lift boxes of up to 20 pounds each.
Bachelor's degree strongly preferred
Just as Virginia Mason is dedicated to improving the lives of our patients and our community, we are equally dedicated to your professional and personal success. With a wide range of perks that includes comprehensive compensation and benefits, continuing education and support, and the opportunity to live in one of the country’s most livable cities, you will find that an opportunity with Team Medicine is one worth taking.
For more information or to apply online visit our website at jobs.VirginiaMason.org. EOE,
Clinical Research Assistant
Digestive Disease Institute
Seattle, WA
Full-time, 40 hours/week
Monday - Friday, 8 am - 5 pm
The hourly salary range for this position starts at $17/98/hour and increases with years of relevant work experience.
Located in Seattle, WA, Virginia Mason Medical Center is an internationally recognized leader in the continuous improvement of health care. With an extensive list of awards and distinctions that includes our recognition as [insert award], Virginia Mason offers you the opportunity to partner with exceptionally talented peers at every level.
You will contribute to the strength of our Team Medicine approach to collaborative medicine and benefit from the changes enacted through our Virginia Mason Production System—a model that has transformed health care by providing patients with easier access to care, reducing errors, and continuously innovating patient safety and quality that has been adopted by other organizations here and abroad. Join us, and find out how many ways Virginia Mason offers you the chance to focus on what really matters—our patients.
The Clinical Research Assistant supports the operations of federally- and/or commercially-funded clinical, biomedical and/or behavioral research studies involving human subjects under direct supervision.
Applies the research protocol for a limited number of studies under direct supervision. With the research coordinator, helps pre-screen potential subjects and help determine eligibility according to the study protocol. Maintains subject enrollment logs for research study.
Attends research-related meetings (e.g., site initiation meetings, monitor visits). Communicates as directed with sponsor and team. Completes sponsor-required duties in preparation for study monitor visits.
Completes and submits documents for IRB review under direct supervision by clinical research coordinator and/or manager. Completes and submits appropriate Institutional Review Board (IRB) documents and receives approval prior to enrolling subjects; corresponds with the IRB on safety reporting and study modifications, closure to accrual reports, and annual reviews; and maintains regulatory files/binders. Submits closure report to IRB when all visits are completed and adverse events have been resolved; ensures that study documentation is accounted for, organized and archived.
Fulfills subject care requirements including but not limited to: appointment scheduling, helping to plan for subject visits by preparing/reviewing charts and laboratory kits, arriving, performing vital signs, subject health assessment, follow-up scheduling, and upholding protocol compliance and subject safety. Maintains subject and document confidentiality at all times.
Performs phlebotomy and specimen (blood/stool/urine/biopsy) processing/routing using universal precautions. Handles dry ice and ships specimens according to protocols daily.
Provides appropriate study-related education and updates to the applicable clinical staff in a timely manner.
Maintains current, accurate documentation including subject information, to research coordinator/PI as appropriate. Provides subject-specific reports for investigator review and signature. Transcribes data from source documents to case report forms.
Distributes, inventories, accounts for and returns clinical study medication/devices, lab kits, etc. per FDA regulations and Good Clinical Practices (GCPs) for handling clinical study materials.
Understands and complies with all applicable sponsor requirements and regulations, including the Food and Drug Administration (FDA), GCPs, International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), and established institutional policies and procedures.
Writes scripts while using Electronic Medical Record system used at Virginia Mason. Handles test article and helps facilitate study drug accountability. Completes routine data entry for a variety of studies and maintains study enrollment logs.
Associate's degree or equivalent required. At least one year experience in some healthcare setting. Skill in using word processing and spreadsheet software. Ability to prioritize and implement simultaneous research projects while working under general supervision. Strong organizational skills and aptitude for detail. Knowledge of research guidelines and regulatory requirements established by such federal and state agencies as the FDA, National Institutes of Health (NIH), Benaroya Research Institute (BRI) at VMMC and database collection. CPR certification required; Healthcare Assistant Certification may be required based on position responsibilities (e.g., performing phlebotomy). Completion of: 1) Human Subjects Research Training tutorial and classes; 2) Ethical Human Research training; and 3) shipping and handling of hazardous materials training provided by BRI required within 30 days of hire.
Able to stand and walk for up to five hours a day. Able to lift boxes of up to 20 pounds each.
Bachelor's degree strongly preferred
Just as Virginia Mason is dedicated to improving the lives of our patients and our community, we are equally dedicated to your professional and personal success. With a wide range of perks that includes comprehensive compensation and benefits, continuing education and support, and the opportunity to live in one of the country’s most livable cities, you will find that an opportunity with Team Medicine is one worth taking.
For more information or to apply online visit our website at jobs.VirginiaMason.org. EOE,