Regulatory Affairs Associate, Senior - Seattle, United States - Fred Hutchinson Cancer Center (Fred Hutch)

Description

Regulatory Affairs Associate, Senior

Job ID

27665

Type

Regular Full-Time

Location

US-WA-Seattle

Category

Clinical Research Support Services

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 Senior Regulatory Affairs Associate will work with faculty and staff in the program to ensure all clinical trials are covered for regulatory and patient enrollment compliance, ensure proper regulatory oversight of clinical trials involving investigational new drugs (INDs) and lead a team of Regulatory Affairs Associates and Coordinators.

Responsibilities

The Senior Regulatory Affairs Associate works independently in acting as a liaison for PI(s)/study team and various internal/external regulatory oversight groups for clinical trials involving INDs and in providing internal training related to regulatory policies, procedures, and best practices.

The role combines both regulatory duties and clinical coordination duties to support the protocols in the program. The primary focus will be regulatory compliance by coordinating regulatory submissions and monitoring as well as assisting with the resolution of compliance issues. The incumbent is expected to work independently within a framework of established regulations and guidelines and demonstrate initiative and sound judgment in problem solving and providing regulatory guidance. Clinical research studies in the program include both investigator-initiated and industry-initiated protocols. The incumbent will prepare IRB documents and FDA correspondence, maintain regulatory files, and facilitate regulatory oversight of safety reporting. The role includes some coverage of the clinical monitoring of studies for compliance. This position requires independent decision making in all aspects of the research study start up process as well as ongoing regulatory study maintenance. This position will be responsible for expeditious coordination of the regulatory submissions in the study start-up phase to meet sponsor and institutional timelines.

May perform some or all of the following responsibilities:

Lead Regulatory Affairs Associates and Coordinators in the regulatory management of clinical trial portfolio
• Independently prepare IRB documents, draft consent form and study documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
• In concert with IND Sponsors, prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
• Lead study start-up: prepare and submit all required regulatory documents for new study applications and successfully open new studies from inception to accrual.
• Maintain study regulatory binders and electronic files in accordance with institutional and sponsor requirements.
• Direct the clinical team to ensure all facets of each protocol are compliant and fully covered.
• Report non-compliances and unanticipated problems to the IRB as applicable.
• Serve as liaison for PI/study team, IND oversight committee, medical monitor and the FDA
• Independently draft FDA correspondence and review correspondence drafted by PI/study team
• Prepare, ship, maintain and archive all submissions to FDA
• Develop policies, procedures, templates, etc. associated with IND oversight committee/charter serious adverse event (SAE) reporting requirements (template language for protocols, reporting forms, instructions, etc.)
• Maintain investigator regulatory files
• Provide training to study team on safety reporting policies associated with protocols under IND
• Develop databases to maintain essential safety, efficacy and other study-related data
• Prepare scheduled and ad hoc reports for ongoing review of safety data and IND annual reports
• Other duties as assigned.

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor's degree or equivalent combination of education and experience.
• Minimum 5 years of regulatory/IRB related experience in a clinical research environment.

PREFERRED QUALIFICATIONS:

• Clinical research related certification preferred
• Prior experience working with E-Binders (e.g. Florence)
• Preparing and reviewing Human Subjects Research applications and IRB exemptions
• Communications with the IRB, and communications with FDA occasionally and preparing for FDA inspections
• Assessing risk in the conduct of clinical research
• Designing tools for the regulatory management of clinical trials
• Interpreting federal regulations and guidelines
• Working with all levels of a research team
• Familiarity with process improvement principles
• Strong verbal and written communication skills
• Knowledge of regulations and guidelines that govern clinical research and human subjects research compliance, including, but not limited to FDA and Good Clinical Practice regulations
• Ability to work collaboratively and build relationships across large organizations

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 $93,100.80 to $139,630.40, 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 days per year), paid sick leave 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 or by calling