Research Coordinator 2

Job Description

The Division of Cardiology in the Department of Medicine has an outstanding opportunity for a full-time Research Coordinator 2.

The purpose of this position is to promote the research objectives of the Clinical Trials Unit (CTU). This position works with Division of Cardiology faculty to facilitateinvestigator-initiatedand industry sponsor drug and device clinical trials. This position is responsible for implementing multiple research projects in human subjects.

About this Opportunity

This position reports to the Clinical Research Manager and will utilize operational knowledge of the University of Washington a firm understanding of the clinical research process and an ability to integrate this knowledge with research priorities to implement program goals. The Clinical Trials Unit supports a diverse portfolio of clinical research studies with a broad reach of diseases and patient populations a portfolio of early to late phase clinical trials and both drug and device interventional studies. This is an excellent opportunity to gain experience as a Research Coordinator in a broad array of study types.

The CTU provides investigator support on all aspects of heart andvasculardiseasefor investigator initiated government and industrysponsoredclinicalresearch studies. The CTU supports and manages Human Subjectsregulatory and financial oversight to ensure efficient execution of studies with the highest quality data.

DUTIES AND RESPONSIBILITIES

This position must be able to work independently on multiple research projects with minimal written policies or procedures. This position requires daily interaction with industry sponsors (pharmaceutical and device) physicians and other healthcare personnel (nurses patient care coordinators etc) and patients. Up to 10 projects will progress simultaneously with an expectation of additional projects in the future.

Protocol Management - 40%

With minimal guidance implement research project procedures that meet research objectives and ensure compliance with all aspects of Institution and federal regulations. This position will be responsible for all aspects of multiple clinical trials including patient recruitment and management study data collection and management and study administration.

Develop document and maintain procedures for patient registration and activities and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.

Coordinate and conduct study visits and activities record and collect study data complete data entry maintain study source records and resolve queries based on source documentation.

Work with Regulatory Coordinator to develop and implement study tools and source documents maintain regulatory documents and review and complete regulatory submissions to Institutional Review Boards and other regulatory and reviewing boards.

Work collaboratively with the research team (regulatory coordinator research assistants) to ensure that projects are executed successfully and completed within the required time frames to meet research objectives and metrics.

Data & Patient Management 40%

Responsible for facilitating and tracking study visits tests and procedures in accordance with the protocol ensuring billing compliance and accurate and complete data collection including informed consent forms and source documentation.

Obtain abstract and code clinical information from multiple sources (medical records research records etc) for research participants in order to enter data into study specific data capture systems and to document assess and report adverse events and safety data to study investigators sponsors IRBs and other regulatory authorities when applicable.

Work with monitors and sponsors to facility study site visits and and with limited guidance to develop and implement corrective action plans to ensure protocol adherence and data integrity and to resolve queries in a timely manner.

Communication & Administration 20%

A good working knowledge of each protocol and familiarity with patient populations diseases and clinical service line operations necessary to manage assigned study portfolio.

Effective and timely communication with industry sponsors and sponsor affiliates physicians clinical service lines and patients is an essential part of this position.

This position will independently manage multiple projects simultaneously routinely work under specific timelines or deadlines with specific timelines or to meet deadlines and often may require a high degree of prioritization and adaptability.

MINIMUM REQUIREMENTS

• Bachelors degree in biological sciences or 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.

DESIRED QUALIFICATIONS

• Prior experience with industry-sponsored and/or interventional clinical trials.
• Effective written and oral communication skills.
• High attention to detail and demonstrated excellent organizational skills
• Demonstrated problem-solving skills and comfort being flexible and adapting in a fast-paced environment
• A self-starter with ability to work independently with limited guidance or in novelty

CONDITIONS OF EMPLOYMENT

• Office location in the UW Health Sciences Building. May require climbing stairs to access office location. Must have flexibility to meet programmatic needs by adjusting work schedule; ability to travel to meetings off site.

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Compensation Benefits and Position Details

Pay Range Minimum:

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Other Compensation:

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Temporary or Regular

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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 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.

To request disability accommodation in the application process contact the Disability Services Office at or .

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.