Research Coordinator 3 (E S UAW Research)

Job Description

The Department of Medicine: Hematology and Oncology has an outstanding opportunity for a Research Coordinator 3 to join their team.

The Clinical Research Coordinator 3 will have a crucial role in the successful operation and management of clinical trials within the Cancer Vaccine Institute (CVI) research portfolio. The Research Coordinator works closely with the Principal Investigator Co-Investigators Research Manager Research Coordinators and lab-based personnel who specialize in translational immunotherapy research. This position will work as a member of the clinical research team that conducts primarily Phase I and Phase II clinical trials to test immune-based therapies for cancer.

The candidate must be able to work in a fast-paced environment and utilize their resourcefulness independent problem-solving skills excellent time management skills attention to detail and be adept at communicating with patients and faculty.

This position requires operational knowledge of the University of Washington and Fred Hutch Cancer Center understanding of medical oncology expert knowledge of research and regulatory operations with an ability to effectively facilitate study workflow on behalf of the Principal Investigators.

This position must be able to work independently managing multiple research projects with minimal written policies or procedures. This position requires daily interaction with research staff patients healthcare personnel and study partners.

The UW Medicine CVI mission is to conduct basic and clinical cancer research that leads to the development of effective immune-based cancer therapies and diagnostic tests. The Research Coordinator 3 will play a key role in managing the implementation of clinical trials that test new cancer therapies.

The Research Coordinator 3 (RC3) will manage research protocol procedures that meet research objectives and ensure compliance with all aspects of Institution and federal regulations. The RC3 will supervise up to 2 research coordinator staff and oversee study operations performed by those staff reporting directly to the CVI Clinical Trials Director. This position will also be responsible for managing all aspects of clinical trials assigned to them relating to recruitment administration long term follow-up and close-out of studies.

The RC3 will work closely with the CVI immune monitoring lab; the UW Translational Research Unit; the FH Cancer Concortium IRB and clinical research support; and additional UW/FH clinical departments that provide research services.

DUTIES AND RESPONSIBILITIES

Study management - 50%

• Manage all aspects of multiple clinical trials facilitating safe efficient and accurate study administration from patient recruitment and enrollment through treatment data collection and trial closeout.
• Facilitate and track complex 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.
• Independently obtain and abstract clinical information for research participants in order to conduct preliminary patient eligibility assessment enter data into study specific data capture systems and document assess and report adverse events and safety data to study investigators sponsors IRBs and other regulatory authorities when applicable.
• Work with study monitors to develop and implement corrective action plans to ensure protocol adherence and data integrity and to resolve queries in a timely manner.
• Communicate with patients to discuss logistical and scientific aspects of clinical trials assess preliminary eligibility and assess interest in clinical trials.
• Participate in informed consent process for potential patients involving minimal risk procedures.
• Maintain regulatory documents and collaborate with regulatory manager to review and complete regulatory submissions to Institutional Review Boards and other regulatory and reviewing boards.
• Develop and implement study tools and source documents.

Team management and development - 25%

• Supervise research study staff assigning studies appropriate to their role and skill level and providing training necessary for them to succeed in study administration.
• Work collaboratively with the entire research team (faculty research scientists research coordinators research manager health care staff) to ensure that projects are executed successfully and completed within the required time frames to meet research objectives and metrics.
• Ensure study staff maintains research protocol procedures that meet research objectives and operate in compliance with institution and federal regulations.
• Ensure study staff maintains billing compliance and accurate and complete data collection.
• Assist study staff as needed with monitoring visits to ensure quality detect problems and develop and implement corrective action plans to ensure protocol adherence and data integrity and to resolve queries in a timely manner.
• Provide backup assistance to study staff when deadlines or other circumstances demand.
• Consult with regulatory manager to maintain required regulatory documents and submissions to Institutional Review Boards and other regulatory and reviewing boards.
• Provide training for study staff providers ancillary staff and other stakeholders to ensure safe and accurate protocol implementation.

Operations management - 25%

• Communicate with Primary Investigators co-investigators referring providers clinical service partners sponsors and patients in an effective and timely fashion.
• Maintain working knowledge of each active protocol familiarity with patient populations diseases and clinical service operations in order to manage study portfolio.
• Independently manage and prioritize multiple projects simultaneously while adhering to specified timelines. Assess workflow needs of the clinical coordination team and assign or delegate tasks to team members as needed to accomplish goals and meet specified deadlines.
• Oversee institutional study start-up processes related to study conduct and clinical operations
• Participate in the development of clinical protocols informed consents patient facing materials and the design and creation of data collection instruments.
• Develop and participate in discussion of quality control quality assessment and process improvement activities.

MINIMUM REQUIREMENTS

• Bachelors Degree in Scientific or health-related field
• At least 4 years experience as a Research Coordinator working with clinical trial participants

Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements such as a license/certification/registration.

ADDITIONAL REQUIREMENTS

• Experience administering complex clinical trials preferably in an oncologic setting
• Experience in training study staff in all aspects of clinical trials operations.

DESIRED QUALIFICATIONS

• Oncology clinical trial experience preferred.
• Previous experience with CTMS OnCore Florence and Epic is strongly desired.
• Knowledge of UW and/or Fred Hutch policies and procedures.
• Attention to detail and project management skills and experience.
• Well organized and ability to multi-task often with conflicting and competing deadlines.
• Excellent written and verbal communication skills.
• Self-starter with the ability to locate resources and operate productively in an environment where standard operating procedures guidelines and policies are not always available.
• Commitment to developing and supporting an effective flexible and dedicated team
• Ability to manage a dynamic research team in a fast-paced academic environment.
• Ability to work collaboratively with individuals and teams within the institution as well as with patients faculty sponsors and referring providers.
• Ability to independently problem solve while maintaining adherence to study protocols and institutional policies.
• Courteous respectful and professional attitude and behavior at all times.
• Able to work independently whilst also being a team player; to maintain flexibility as priorities change maintaining a professional demeanor at all times.

Working Environmental Conditions

• The Cancer Vaccine Institute is located at the UW Medicine at South Lake Union campus in a translational research environment that includes laboratory clinical research and administrative office areas.
• This position requires some off site travel to University of Washington Medical Center Fred Hutch Bloodworks Northwest. A shuttle is available.
• Work is typically deadline driven and requires a high level of accuracy extensive communication with staff and external collaborators from diverse backgrounds.
• This position may at times require a flexible work schedule in support of clinical trials.
• Stringent deadlines for protocol implementation data collection integrating required elements of research into complex patient schedules and special event coordination may require occasional evening or weekend work.

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Compensation Benefits and Position Details

Pay Range Minimum:

Pay Range Maximum:

Other Compensation:

Benefits:

Temporary or Regular

FTE (Full-Time Equivalent):

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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.