Research Coordinator

Job Description

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.

• The Research Coordinator will independently perform a variety of assessments including cognitive testing and scoring for multiple participant visits, and complete all study-related forms, including consent, data collection and validation.

• The research coordinator is responsible for recruiting, scheduling, identifying, and consenting study subjects for multiple, concurrent research studies, through the use of research registries, electronic health record systems, and other recruitment tools.

• Produce written communications pertaining to study content. Prepare and track study follow-up activities to ensure subsequent study participation timelines and requirements are met.

• Directly respond to study content queries from participants, family members, collaborating providers and staff.

• The research coordinator will acquire and retain study data, perform data evaluations and assess data collection activities performed by other members of the study team including but not limited to other research coordinators, graduate and undergraduate trainees.

• Process human subject specimens including blood and spinal fluid, as well as manage freezer specimens for sample send-outs in accordance with federal and institutional biologic shipping regulations.

• Assist collaborators at the Alzheimer’s Disease Research Center (ADRC) with additional study procedures and conduct, as needed and with the approval and oversight of the PI.

• Manage study materials ordering and inventory.

• The research coordinator will be responsible for meeting enrollment milestones, ensuring that projects are executed successfully and completed within needed timeframes to meet research objectives.

• The research coordinator is responsible for advising investigators of identified enrollment barriers and devising protocol revisions that will address these identified barriers.

• The research coordinator will provide cross coverage support for the other research coordinator and research study coordinators.

Other Special Projects & Training/Supervision As Needed (10%)

• Supervises, assigns work to and assesses the accuracy of acquired data by undergraduate and graduate student employees.

• Responsible for orienting new research group members to study protocols and training group members to conduct interventions.

• Assist the PI with the supervision of work-study students and volunteers on the studies.

MINIMUM REQUIREMENTS

• Bachelor’s degree in Health Sciences or related field and one year of relevant experience.

Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

ADDITIONAL REQUIREMENTS

• Candidates will be required to complete blood-borne pathogens training, CITI research ethics training (Good Clinical Practice) or equivalent, UW lab safety training, and HIPAA training .

DESIRED QUALIFICATIONS

• Familiarity with RedCAP.

• Experience with healthcare research and electronic medical records systems.

• Experience with diverse/vulnerable populations and direct patient/family/caregiver contact for administration of questionnaires.

WORKING CONDITIONS

The study requires travel to UWMC – Montlake campus, South Lake Union campus, and Harborview Medical Center campus to consent participants and administer surveys and interventions.

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Compensation, Benefits and Position Details

Pay Range Minimum:

$60,000.00 annual

Pay Range Maximum:

$69,600.00 annual

Other Compensation:

Benefits:

For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/

Shift:

First Shift (United States of America)

Temporary or Regular?

This is a regular position

FTE (Full-Time Equivalent):

100.00%

Union/Bargaining Unit:

UAW Research

About the UW

Working at the University of Washington provides a unique opportunity to change lives – on our campuses, in our state and around the world.

UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty.

Our Commitment

The University of Washington is proud to be an affirmative action and equal opportunity employer . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.

To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu .

Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law .