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The University of Washington Department of Pathology is a dynamic organization, one of the best in the country that has had a consistent level of high achievement in all of its activities. The Department offers full diagnostic service in all areas of pathology and is one of the top ranked Departments of Pathology as a recipient of research grant funding National Institutes of Health. Our educational and training programs include the Pathology Residency Training Program, the Molecular Medicine and Mechanisms of Disease Ph.D. and the teaching of medical students, postdoctoral research fellows and clinical fellows.
The Department of Pathology currently has an outstanding opportunity for a RESEARCH COORDINATOR. This position coordinates research collection of biospecimens, including pathology archival collections, and associated clinical information.
This position has operational access to patient health information and clinical materials including pathology specimens and archival blocks and slides, and for these activities must adhere to the covered entity HIPPA Privacy and CLIA rules and has 'dotted line' reporting to the CLIA certificate holders and applicable clinical laboratory management staff.
1) Management of Research Protocol Applications and Administrative Duties:
a)Review initial research requests to determine if requirements have been met for collection, including IRB approvals as necessary.
b)Assess the potential impact of tissue research requests on other tissue collection efforts/applications per a Specimen Use Advisory Committee (SUAC) approved request prioritization schedule.
c)Present reviewed applications to overseeing pathologist (CLIA holder or designee) and Specimen Use Advisory Committee (SUAC) as required for final approval
d)Develop Statements of Work and budgets for registered studies, grant proposals and Clinical Trials.
e)Maintenance of database on tissue collection applications (Specifics of request, IRB status, Funding source, required regulatory documents, etc.)
f)Implement procedures to assure protocol compliance and research data quality. Develop and implement corrective action plans to ensure protocol adherence and data integrity
g)Ensure compliance with all policies and regulations regarding specimen research in human subjects of the Institutions involved in the use of research tissue including UW, FH, SCCA, Clinical Laboratory Improvement Amendments of 1988 (CLIA) and College of American Pathologists (CAP), Federal Drug Administration (FDA), Office for Human Research Protections (OHRP), and National Institutes of Health(NIH)
h)Communicate with NWBioSpecimen Assistant Director concerning specimen requests, status of requests, implementation issues, compliance issues, deviations from protocol and required protocol modifications. Prepare interim reports to ensure that each request is moving toward timely completion. Collaborate with NWBioSpecimen Assistant Director to improve processes and protocols to enhance and exceed Resource objectives.
i) Use spreadsheets and complex database software to process billing, monitor budgets, track research accounts and create monthly reports, including billing reports. Work with PIs, grant managers and research coordinators for billing issue resolution in conjunction with accounting students.
j) Abstract clinical information from medical records or compile histological details. Compilation of clinical information may involve collaboration with programmers, digital imaging staff and pathologists.
2) Screening and Consent/Authorization:
a)Review of clinical record systems to screen for cases that are eligible for registered projects (both prospectively identified per the OR and clinic schedules and archival cases).
b)Ensure that appropriate consents/authorizations are obtained and, if the collection of specimens or data is done under approved consent authorization waivers or non-human subjects determinations, that the patient has not declined the NWBioTrust global consent.
c)Obtain NWBT protocol consent (including research only biospecimens) pre-operatively or in clinic areas as needed.
d)Obtain study specific consents per IRB approved procedures.
e) Obtain biospecimens within an approved Surgical Pathology or Lab Medicine stream. Collections and processing activities cover multiple areas and this position will rotate between these areas as needed.
i)Clinic or pre-operative area: gathering of IRB approved clinical information such as questionnaires and research only samples such as buccal swabs, urine and blood samples.
ii)Operating rooms/Radiology: Intraoperative blood work with anesthesia teams, research only biopsies in the Operating Room and interventional Radiology suites, and sterile intra-operative biospecimen collections with a Pathologist Assistant, Pathologist and/or moonlighting Pathology trainee.
iii)Pathology gross rooms and frozen section areas: non-sterile collections of tissue and processing of specimens after remnants of clinical specimens have been released by pathology attendings, senior residents or pathology assistants.
f) Ensure that documentation of research tissue collections is in the surgical pathology report.
g) Ensure specimen is either placed in appropriate short-term storage in the Research Tissue Acquisition Space or directly handed off to investigator.
h) Ensures that specimen and annotation data hand off has occurred and is documented appropriately, including within the BioSpecimen Management System (Labmatrix).
Archival BioSpecimen Procurement :
i) Document archival order steps in electronic ticket system, and track order status with timely communications with research teams.
j) Retrieve pathology archival materials from on-site storage areas and from off-site archives. Track all archival material flows in anatomic pathology laboratory information systems (AP-LIS), such as PowerPath and associated programs and in a BioSpecimen Management System (Labmatrix).
k) Coordinate the authorization of CLIA materials for research use by either the CLIA holder or designee.
l) Order lab requests in AP-LIS, communicate research order details with lab personnel such as histotechnicians, monitor completion of request per standard turn around times, and coordinate the distribution of requested materials to the research team. Ensure that appropriate documentation and audit trails are complete at each step.
This position may train other personnel, including students, as needed. Other duties may be assigned.