Clinical Research Intake Specialist

Job ID
20978
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Clinical Research Support Services

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization.  We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

 

The Clinical Trial Management System (CTMS) is a commercial software system, OnCore, that supports clinical research functions across Fred Hutch, the University of Washington (UW) and the Seattle Cancer Care Alliance (SCCA). The system is managed by a Program Office that is responsible for system maintenance, workflows, end user training and reporting. The CTMS Intake and Support Specialist will provide intake processing and overall status tracking of new studies and amendments as they are submitted by study teams via REDCap. This position will also act as a liaison, provide product/services information, and resolve any problems that our CTMS customers might face during the startup and amendment processes.  The person will work closely with the parallel offices at the SCCA, UW and FH to ensure protocol submissions are complete and meet standards as applicable to each protocol type.  This position will work closely with the data analyst to QC various data elements and ensure completeness of the data to support the detailed metrics collected to track the clinical research process. This position will work with the process owners to design and test workflow changes as recommended by the Clinical Trials Process Improvement process.  This position will provide support for operational process workflows as it relates to the CTMS, and will work across the organization’s clinical research offices to align CTMS operations with institutional processes and requirements.

Responsibilities

  • Perform intake processing on REDCap submission for initial and amended clinical research protocols
  • Build protocols in OnCore CTMS based on REDCap submission ensuring high data quality and timeliness
  • Analyze errors or one-off exceptions for protocols during startup and determine corrective actions to ensure submission can continue smoothly
  • Develop processes and Standard Operating Procedures (SOPs) related to the responsibilities of this position
  • Perform QC of the operational responsibilities of this position, resolve errors and develop process improvements to reduce errors.
  • Synthesize operational inputs and experience to update training documentation for internal processes and inform QC processes as needed
  • Handle escalated issues and follow-up on outstanding issues promptly directly with users and/or external department administrators.
  • Facilitate transfer of protocols and subjects to Epic via the integration. Work with the CTMS Product Manager on resolution of errors.
  • Analyze reports and CTMS information to open protocols to accrual as needed
  • Identify and resolve operational issues within the defined schedules and service level agreements.
  • Analyze root causes of operational malfunctions and provide resolutions.
  • Contribute to business meetings and report on issue status.

Qualifications

MINIMUM QUALIFICATIONS:

  • 2-3 years experience in clinical research
  • Bachelor’s Degree
  • Strong skills with use of Microsoft Office Suite
  • Outstanding customer service skills
  • Strong quantitative and analytical skills
  • Collaborative worker and teambuilding ability
  • Able to work under a flexible schedule
  • Knowledge of content management systems
  • Familiar with academic research environment
  • Comfort learning new electronic systems

PREFERRED QUALIFICATIONS:

  • CTMS experience, preferably OnCore experience
  • Clinical research related certification preferred
  • Familiarity with REDCap application
  • Strong verbal and written communication skills

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment. 

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.

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