FHLB Des Moines
**Job Description**As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills, and dedication to build stronger minds and a healthier world.UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits, and natural beauty.**The Division of Gerontology and Geriatric Medicine at Harborview Medical Center****has an outstanding opportunity for a Research Coordinator to join their team.**The Division of Gerontology and Geriatric Medicine at Harborview Medical Center has an opportunity for a Research Coordinator to lead and manage clinical trials and studies focused on Alzheimer's Disease and related dementias. Working with the Principal Investigator, the Research Coordinator will be responsible for implementing clinical interventional trials within vulnerable patient populations. These clinical research studies are conducted in older adults to investigate how the brain responds to acute meal and nutrient interventions, and to assist with clinical trials involving diabetes medications and cognitive interventions including crossword puzzles.The Research Coordinator will employ established best practices to ensure that all research meets or exceeds requirements while maintaining appropriate patient confidentiality and furthering the research objectives of the Hanson Laboratory. This position will be responsible for orienting and educating faculty investigators, staff at collaborating enrollment sites, and Alzheimer’s Disease Research Center staff to clinical protocols and expectations. The Research Coordinator will identify, recruit, and consent clinical research subjects with varying levels of cognitive ability as well as their family members and caregivers. The Research Coordinator will use independent judgment, problem-solving skills, and project management skills to ensure that each of the research projects meets established benchmarked deliverables. Finally, the Research Coordinator will assist the PI in training and supervising study staff and work-study students and run weekly lab meetings.
To support this endeavor, the Alzheimer’s Disease Research Center provides workshops for senior Coordinators who will conduct talks and mentor new Coordinators on topics such as informed consent, trial design, etc.Research Study Coordinator training is required because this position will work with protected health data and human subjects within UW Medicine.
The training requirement for this position includes UW Medicine-specific and general training such as Good Clinical Practice, HIPPA, biosafety, etc., and will be provided during position onboarding.**Position Complexities:**This position requires independent judgment, leadership, and expert knowledge of clinical research and regulatory operations to effectively facilitate study workflow on behalf of the Principal Investigator.
The position will maintain dynamic communication with the study investigators, research staff, numerous University departments, federal agencies, and industry partners. This position is required to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University and federal regulatory agencies. Additionally, the RC will coordinate multiple data collection efforts which will include other collaborating agencies and institutions nationally, including the NIH. The RC will recruit human subjects, write and edit reports, develop and monitor reports, work with funding agencies, and train/direct the work of assigned staff in related areas.**Position Dimensions and Impact to the University:**This position supports and leads research, contributing to the UW’s reputation as a research leader.This is a 1.0 Research Coordinator position in a research group focusing on Alzheimer's Disease and related dementia.
The Hanson research group is funded by both federal and non-federal funding sources and has 4-6 interventions occurring concurrently.**DUTIES AND RESPONSIBILITIES*****Regulatory Affairs and Study Development (50%)***This position has the overall responsibility for ensuring that the Alzheimer’s Research Program clinical trials meet regulatory requirements and are compliant with federal and institutional policies. This will necessitate research protocol submissions to various institutional and external IRBs, ongoing tracking of annual IRB renewals, submission of annual reviews, modifications to existing protocols, SAEs, and protocol deviations to the appropriate IRB. This position must be able to work with minimal supervision on multiple research projects. This position supervises and works closely with the other RCs on the Alzheimer's Disease studies and requires daily interaction with physicians/PIs, research staff at collaborating institutions, pharmaceutical company sponsors, and any other groups integral to the successful completion of research projects.•
Oversee regulatory affairs coordination as outlined by protocol objectives. This includes becoming familiar with the active Alzheimer’s clinical trials and submitting IRB applications and modifications in a timely fashion.•
Write/edit clinical research consent forms in accordance with CFR and FDA guidelines, ensuring all appropriate “Elements of Informed Consent.” Translate complicated research protocol requirements into language easily understandable by research participants.•
Assist faculty in writing Investigational New Drug applications and annual reports for investigator-initiated clinical trials. Coordinate initial and ongoing submissions, and annual reports to the Food and Drug Administration.•
Maintain and update all required regulatory documents (FDA Form 1572 and/or 1571, Protocol Signature Page, Investigator Brochure, Financial Disclosure, laboratory accreditations, laboratory reference ranges, investigators’ and research staffs’ CVs, medical licensures, and related forms per sponsor or federal requirements)•
Assist in the development of protocols for therapeutic clinic trials as well as minimal risk research projects and chart reviews.•
Conduct Quality Assurance for the Alzheimer’s Research Program. Responsible for conducting quality assurance audits of the Alzheimer’s Research Program trials and ensuring compliance with study protocols, program SOPs, policies, GCP and FDA regulations. The QA procedures include regulatory and clinical compliance reviews of trial activities such as source document verification against data capture systems, consent documentation compliance, and AE, SAE and concomitant medication review.•
Create and maintain written materials in varying media areas, improving external visibility of the research program for the purposes of trial acquisition and subject recruitment.•
Act as a subject-matter-expert in the development and implementation of the use of "plain language" for writing subject-facing materials. Mentor other research staff in the use of plain language.•
Involve Alzheimer’s Research Team Management and Leadership as appropriate to identify and ameliorate bottlenecks with clinical trial implementation; use problem-solving and interpersonal skills with organized process improvement efforts.•
Summarize study results, and prepare reports, perform data validations and accuracy of study information housed in RedCap, OnCore and other UW systems.•
Facilitate sponsor status updates using established milestone reporting deadlines, such as interim reports for the NIH or industry sponsors.***Study Conduct (40%)***•
Using appropriate inclusion and exclusion criteria, the research coordinator will confirm eligibility and conduct this process with the discretion necessary for interactions with vulnerable patient populations.•
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To support this endeavor, the Alzheimer’s Disease Research Center provides workshops for senior Coordinators who will conduct talks and mentor new Coordinators on topics such as informed consent, trial design, etc.Research Study Coordinator training is required because this position will work with protected health data and human subjects within UW Medicine.
The training requirement for this position includes UW Medicine-specific and general training such as Good Clinical Practice, HIPPA, biosafety, etc., and will be provided during position onboarding.**Position Complexities:**This position requires independent judgment, leadership, and expert knowledge of clinical research and regulatory operations to effectively facilitate study workflow on behalf of the Principal Investigator.
The position will maintain dynamic communication with the study investigators, research staff, numerous University departments, federal agencies, and industry partners. This position is required to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University and federal regulatory agencies. Additionally, the RC will coordinate multiple data collection efforts which will include other collaborating agencies and institutions nationally, including the NIH. The RC will recruit human subjects, write and edit reports, develop and monitor reports, work with funding agencies, and train/direct the work of assigned staff in related areas.**Position Dimensions and Impact to the University:**This position supports and leads research, contributing to the UW’s reputation as a research leader.This is a 1.0 Research Coordinator position in a research group focusing on Alzheimer's Disease and related dementia.
The Hanson research group is funded by both federal and non-federal funding sources and has 4-6 interventions occurring concurrently.**DUTIES AND RESPONSIBILITIES*****Regulatory Affairs and Study Development (50%)***This position has the overall responsibility for ensuring that the Alzheimer’s Research Program clinical trials meet regulatory requirements and are compliant with federal and institutional policies. This will necessitate research protocol submissions to various institutional and external IRBs, ongoing tracking of annual IRB renewals, submission of annual reviews, modifications to existing protocols, SAEs, and protocol deviations to the appropriate IRB. This position must be able to work with minimal supervision on multiple research projects. This position supervises and works closely with the other RCs on the Alzheimer's Disease studies and requires daily interaction with physicians/PIs, research staff at collaborating institutions, pharmaceutical company sponsors, and any other groups integral to the successful completion of research projects.•
Oversee regulatory affairs coordination as outlined by protocol objectives. This includes becoming familiar with the active Alzheimer’s clinical trials and submitting IRB applications and modifications in a timely fashion.•
Write/edit clinical research consent forms in accordance with CFR and FDA guidelines, ensuring all appropriate “Elements of Informed Consent.” Translate complicated research protocol requirements into language easily understandable by research participants.•
Assist faculty in writing Investigational New Drug applications and annual reports for investigator-initiated clinical trials. Coordinate initial and ongoing submissions, and annual reports to the Food and Drug Administration.•
Maintain and update all required regulatory documents (FDA Form 1572 and/or 1571, Protocol Signature Page, Investigator Brochure, Financial Disclosure, laboratory accreditations, laboratory reference ranges, investigators’ and research staffs’ CVs, medical licensures, and related forms per sponsor or federal requirements)•
Assist in the development of protocols for therapeutic clinic trials as well as minimal risk research projects and chart reviews.•
Conduct Quality Assurance for the Alzheimer’s Research Program. Responsible for conducting quality assurance audits of the Alzheimer’s Research Program trials and ensuring compliance with study protocols, program SOPs, policies, GCP and FDA regulations. The QA procedures include regulatory and clinical compliance reviews of trial activities such as source document verification against data capture systems, consent documentation compliance, and AE, SAE and concomitant medication review.•
Create and maintain written materials in varying media areas, improving external visibility of the research program for the purposes of trial acquisition and subject recruitment.•
Act as a subject-matter-expert in the development and implementation of the use of "plain language" for writing subject-facing materials. Mentor other research staff in the use of plain language.•
Involve Alzheimer’s Research Team Management and Leadership as appropriate to identify and ameliorate bottlenecks with clinical trial implementation; use problem-solving and interpersonal skills with organized process improvement efforts.•
Summarize study results, and prepare reports, perform data validations and accuracy of study information housed in RedCap, OnCore and other UW systems.•
Facilitate sponsor status updates using established milestone reporting deadlines, such as interim reports for the NIH or industry sponsors.***Study Conduct (40%)***•
Using appropriate inclusion and exclusion criteria, the research coordinator will confirm eligibility and conduct this process with the discretion necessary for interactions with vulnerable patient populations.•
The #J-18808-Ljbffr