Research Coordinator 3 (E S UAW Research)

University of Washington•Seattle, WA

About The Position

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.

Requirements

Bachelor's 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.
Experience administering complex clinical trials, preferably in an oncologic setting
Experience in training study staff in all aspects of clinical trials operations.

Nice To Haves

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.

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, IRB’s 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.