FreshRemote.Work

Sr. Regulatory Coordinator, eRegulatory Support

Seattle, WA, United States

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

 

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

 

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

 

The department of Clinical Research Support (CRS) is the central clinical trials office for the University of Washington/Fred Hutchinson Cancer Research Center Cancer Consortium. The Sr. Regulatory Coordinator is responsible for preparing documentation for industry sponsored, investigator initiated, and national cooperative group clinical trials. The position will report to the CRS Director of Operations.

 

This is a remote position.

Responsibilities

  • Assist with preparation, routing and mainteance of staff training and access for the eReguglatory system according to FDA regulations and internal policy. 
  • Maintain training and guidance documents for study teams on system utilization, best practices and internal policies for eRegulatory binders and eConsent. 
  • Manage and maintain staff training and permissions for eRegulatory system.
  • Support study teams in building and optimizing their team binders within the eRegulatory platform.
  • Supporting integration workflow solutations between eRegulatory and other workflows (CTMS, etc.)
  • Assist in preparing and creating materials for data collection within the eRegulatory system, providing electronic source data solutions.
  • Assist with follow-up and issue resolutions related to eRegulatory access and concerns identified by study teams.
  • Assist with completion of regular Quality Control checks of the eRegulatory system in both eBinders and eConsent to ensure internal policies and procedures are being followed for training and access to the eRegulatory system. 
  • Report quality issues and unanticipated problems related to eRegulatory features.
  • Support tracking and reporting of key eRegulatory metrics.
  • Support central inbox maintenance and response/escalation to inquiries.

Qualifications

MINIMUM QUALIFICATIONS:

  • Bachelor’s Degree in biological, social or physical science. 
  • 2 years of regulatory, clinical trials and/or prevention study management experience
  • Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH)
  • Experience reviewing IRB documentation and research protocols
  • Ability to work collaboratively and build relationships across a large organization
  • Excellent written and verbal communication skills including the ability to communicate clearly, succinctly and effectively over the phone and in writing
  • Excellent time management skills
  • Advanced knowledge of MS Word and Acrobat

PREFERRED QUALIFICATIONS:

  • Master’s degree
  • Experience with eRegulatory systems (i.e. Florence)
  • Experience writing technical documents 
  • Clinical research related certification 

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.

The annual base salary range for this position is from $76,606 to $114,878, and pay offered will be based on experience and qualifications.  Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months). 

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 Human Resources at hrops@fredhutch.org or by calling 206-667-4700. Apply

Job Profile

Regions

North America

Countries

United States

Skills

Acrobat Clinical trials Clinical Trials Management Data Collection GCP ICH MS Word Quality Control Regulatory Compliance

Tasks
  • Assist in data collection within eRegulatory system
  • Maintain staff training for eRegulatory system
  • Prepare eRegulatory documentation
  • Report quality issues related to eRegulatory
  • Support study teams in eRegulatory platform
Experience

2 years

Education

Bachelor's Degree in biological Physical Science Social

Timezones

America/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9