Sr. Regulatory Coordinator

Home Health Focus AI; Seattle (WA); Remote; USD 78,000 - 119,000; Full time

Job summary

An established industry player in cancer research is seeking a Sr. Regulatory Coordinator to join their remote team. This role is pivotal in preparing regulatory documentation for various clinical trials, ensuring compliance with FDA regulations, and maintaining accurate records. The ideal candidate will have a strong background in clinical trials management and excellent communication skills. You will be part of a collaborative environment dedicated to groundbreaking research and improving patient outcomes. If you are passionate about making a difference in the field of healthcare and thrive in a dynamic setting, this opportunity is perfect for you.

Benefits

Medical/Vision Insurance

Dental Insurance

Flexible Spending Accounts

Life Insurance

Disability Insurance

Retirement Plan

Tuition Reimbursement

Paid Vacation

Paid Sick Leave

Paid Parental Leave

Qualifications

• 2+ years of experience in regulatory and clinical trials management.
• Bachelor's degree in biological, social or physical science required.

Responsibilities

• Prepare and submit regulatory documents for clinical trials.
• Liaise with investigators to ensure accuracy of documentation.

Skills

Written Communication

Verbal Communication

Organizational Skills

Protocol Design

Time Management

Education

Bachelor's Degree in Biological Science

Master's Degree

Tools

MS Word

Adobe Acrobat

Job description

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 Hutch Cancer Consortium. The Sr. Regulatory Coordinator is responsible for preparing documentation for industry sponsored, investigator initiated, and national cooperative group clinical trials.

This is a remote position.

Responsibilities

• Supporting trials within GUMO, Breast, Nuclear Medicine and other indications
• Prepares and submits regulatory documents to the IRB including initial application, annual renewal, and modifications for industry sponsored, investigator initiated, and national cooperative group clinical trials
• Establishes and maintains Cancer Consortium and Sponsor regulatory files
• Creates and maintains study-related tools and templates for the start-up and regulatory management of clinical trials
• Prepares local consent forms from industry templates as well as for investigator initiated protocols; provides formatting and editing assistance for investigated initiated trial documents
• Facilitates SAE processing to comply with FDA reporting requirements for IND trials
• Liaises with investigators and study teams to ensure accuracy of documentation
• Extracts data from Institutional databases to report study accrual data
• Extracts data from study data bases for scheduled and ad hoc reports for ongoing review of safety data and IND annual reports

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree in biological, social or physical science or equivalent years of experience.
• 2 years of regulatory, clinical trials and/or prevention study management experience
• Excellent written and verbal communication skills
• Effective organizational skills
• Previous experience with protocol design and review

PREFERRED QUALIFICATIONS:

• Master’s degree
• Experience writing technical documents
• Clinical research related certification
• Ability to communicate clearly, succinctly and effectively over the phone and in writing
• 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 time management skills
• Advanced knowledge of MS Word and Acrobat

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 $78,894 to $118,310, 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 [e-mail] or by calling 206-667-4700.