Clinical Research Study Assistant / Regulatory -- Department of Medicine, Division of Hematology & Oncology (Temporary)

Job Description The Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a temporary Clinical Research Study Assistant to join their regulatory team within the UW Hematologic Malignancies Research Program. This is a temporary, full-time position that is anticipated to last up to 12 months.

About This Opportunity Reporting to the Senior Research Coordinator of the UW Hematologic Malignancies team, the Clinical Research Study Assistant (RSA) provides a variety of support functions to the regulatory team, including administrative and technical support to the research team to collect and maintain staff credentials. The RSA will also provide administrative support to the Regulatory Coordinators to download and screen safety reports, assist with completion of regulatory documents and help obtain signatures. At any one time, upwards of 50 clinical trials may be active across the disease program, and this position is responsible for organizing and prioritizing numerous concurrent tasks and managing both short-term and long-term multi-step tasks.

The RSA works with Division faculty and research staff to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials, implementing multiple research projects to test hypotheses in human subjects. The RSA has daily interactions with research staff, health care personnel (e.g., nurses, patient care coordinators, patient service representatives, medical assistants), pharmaceutical company sponsors, and other groups integral to the successful completion of the research project.

The Research Study Assistant works on-site at the Fred Hutch Cancer Center (FHCC), and project work visits may be required during the work shift at local affiliate locations. The position may be eligible to be considered for a hybrid telework work schedule based on business needs, working remotely up to three days per week, once fully trained and demonstrating telework readiness.

Key Responsibilities Safety Data Coordination, Abstraction and Analysis (30%):

• Work independently to abstract safety data from multiple sources (sponsor portals and reports, etc.) for research analysis by Regulatory Coordinators and Principal Investigators.
• Make independent judgments about the relevance of the safety data to the research for complicated oncology research studies.
• Principally responsible for monitoring and tracking upcoming pharmaceutical sponsor and government audits and maintaining research credentials.
• Understand research study flow and work with research regulatory team members to perform the required research support tasks at appropriate study time points.

Administrative (40%):

• Obtain faculty signatures both in-person and electronically.
• Assist administrative staff with archiving of older documents.
• Regulatory records management.

Credential Coordination (30%):

• Independently maintain and track current and former staff credentials and trainings.
• Obtain laboratory credentials from external facilities.

Perform other related tasks 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 Applicants who do not meet these minimum qualifications WILL NOT be forwarded to the Hiring Manager.

• Two years of college-level course work in a relevant academic area AND one year of appropriate experience.

Additional Qualifications

• Demonstrated understanding of medical terminology
• Strong computer skills and experience with data entry and databases
• Strong attention to detail and ability to organize work
• Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues, research subjects, and study sponsor representatives
• Demonstrated ability to work independently and to carry out complex tasks

Preferred Qualifications

• Bachelor’s degree in science-related field
• Knowledge of oncology practice and terminology
• Prior working experience at the UWMC, FHCC, and/or SCCA
• Prior experience in basic processing laboratory samples
• Competency in Microsoft Office software
• Kn…