Research Coordinator 2

University of Washington; Seattle (WA); Sur place; USD 72 000 - 96 000; Plein temps

Résumé du poste

The University of Washington Department of Neurology is seeking a 100% FTE Research Coordinator 2 to support neurodegenerative research, including Huntington's, Parkinson's, and ataxias.

Reporting to the Principal Investigator, you will coordinate research activities, assist with data collection and management, and ensure regulatory compliance with FDA/NIH requirements.

Qualifications

• Bachelor’s degree in a related field and two years of relevant experience.
• Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements.
• Knowledge and prior experience with human subjects' institutional review process including developing protocols and working with the IRB for approvals.

Responsabilités

• Protocol management to ensure compliance with FDA/NIH regulations and study objectives.
• Recruit, screen, consent, enroll and follow up patients in clinical trials and coordinate associated visits and tests.
• Maintain records of study data and communicate with principal investigators and sponsors.
• Organize audits of study data and ensure protocol adherence with corrective action plans.
• Ensure regulatory documents are maintained in accordance with local and federal requirements.

Connaissances

IRB knowledge

Clinical trials experience

Data management

Project coordination

Regulatory compliance

Formation

Bachelor’s degree in a related field

Two years of relevant experience

Description du poste

Seattle, WA

Full time

REQ-0000137221

Job Description

The Department of Neurology has an outstanding opportunity for 100% FTE Research Coordinator 2.

About This Opportunity

Reporting to the Principal Investigator the Research Coordinator will be responsible for the coordination and implementation of support research focused on neurodegenerative diseases, including Huntington's disease, Parkinson's disease, and ataxias.

This individual will maintain IRB approvals and consent forms, participate in data collection and data management for federal and industry sponsored projects.

This position requires the ability to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor. There are multiple resources available within the University system (e.g. Grant and Contract Services, Institutional Review Board, Office of Industry Relations) to help in this process, but ultimately, the work must be done independently and in a resourceful manner to expedite the research objectives. This individual is also responsible for organizing and facilitating sponsor-initiated, FDA-initiated, and foundation-initiated audits of study data. The individual in this position will aid in furthering the academic pursuit of the UW by contributing their time and knowledge base to our research studies.

Key Responsibilities

Protocol Management - 40%

• Develop and implement research project procedures that meet research objectives and ensure compliance with all aspects of Institution, Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects
• Design, create, revise, and complete research instruments (e.g. case report forms) as necessary to ensure quality data that correlates with research objectives.
• Design, document and implement procedures for audits to assure protocol compliance and to ensure research data quality. Develop and implement corrective action plans to ensure protocol adherence and data integrity.
• Maintain regulatory documents in accordance with local and federal requirements.
• Ensure that projects are executed successfully and completed within required time frames to meet research objectives.

Patient Management - 40%

• Recruit, screen, consent, enroll and follow up patients in clinical trials. Assist in scheduling appointments, ordering tests and procedures to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection.
• Coordinate all aspects of subjects' participation including but limited to: scheduling appointments, ensuring ordering of tests and procedures, billing compliance.
• Implementing patient protocol, interacting closely with clinical providers to ensure patient safety and protocol adherence.
• Communicate with outside physicians who are interested in referring patients to UWMC/HMC for clinical research.
• Understand clinical trial budget and billing plan for patients enrolled on clinical trials. Work with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance and budget.
• Perform other duties as required

Data Management - 20%

• Maintain records of study data.
• Communicate with Principal Investigators, pharmaceutical and equipment company medical personnel in handling results of studies (progress reports, case report forms).
• Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion. Assist in analyzing data to be presented at conferences or published in scientific journals.
• Other duties as assigned.

Required Qualifications

To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

Minimum Qualifications

• Bachelor’s degree in a related field and two years 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.

Applicants who do not meet these qualifications WILL NOT be forwarded to the Hiring Manager.

Additional Qualifications

• Knowledge and prior experience with human subjects' institutional review process including developing protocols and working with the IRB for approvals.
• Experience in clinical trial processes and implementation of research protocols
• Demonstrated ability to work independently with minimal supervision
• Training and/or knowledge in ethical conduct of research with human subjects.
• Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete it within 90 days of hire.

Preferred Qualifications

• Sound knowledge of IRB submission procedures, FDA, GCP, and NIH requirements relating to research involving human subjects
• Certified Clinical Research Professional (CCRP) certification

Compensation, Benefits and Position Details

Pay Range Minimum:

$72,000.00 annual

Pay Range Maximum:

$96,000.00 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 committed to fostering an inclusive, respectful and welcoming community for all. As an equal opportunity employer, the University considers applicants for employment without regard to race, color, creed, religion, national origin, citizenship, sex, pregnancy, age, marital status, sexual orientation, gender identity or expression, genetic information, disability, or veteran status consistent with UW Executive Order No. 81 (https://policy.uw.edu/directory/po/executive-orders/eo-81-prohibiting-discrimination-harassment-and-sexual-misconduct/) .

To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or [e-mail] .

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 (https://app.leg.wa.gov/RCW/default.aspx?cite=28B.112.080) .