Regulatory Affairs Associate - Seattle, United States - SRA International

Description

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 worlds 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 worlds 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 Fred Hutch offers a vibrant intellectual environment within a beautiful lakeside campus in Seattles South Lake Union biotech hub. The Fred Hutch campus contains five major research buildings along with the Seattle Cancer Care Alliance and is in close proximity to major research partners, such as the University of Washington School of Medicine, Seattle Childrens Research Institute and the Allen Institute for Immunology.

The Immunology and Vaccine Development (IVD) Program is a large and diverse program within the Vaccine & Infectious Disease Division (VIDD). The program supports the research of more than 20 Principal Investigators (PIs).

Responsibilities

The Regulatory Affairs Associate ensures proper oversight of investigator-initiated clinical research and lab-based studies. The Regulatory Affairs Associate will serve as a liaison for PI(s)/study team and various internal/external regulatory oversight groups. They will be responsible for coordinating submissions to local regulatory bodies including the Institutional Review Board (IRB) under the supervision of the Regulatory Affairs Manager.

Key Responsibilities

• Provide regulatory support to IVD PIs working in multiple locations including the laboratories, the clinics and other external institutions.
• Use judgment to interpret and apply federal and local regulations regarding research.
• Serve as the subject matter expert for human subjects determinations for laboratory-based research proposals.
• Write and prepare regulatory submissions including applications, renewals, amendments, consent forms, safety reports, study updates, etc. in accordance with required timelines.
• Prepare and coordinate study registration materials/submissions and assist with communications with sponsors and other stakeholders.
• Assist in the development of project/study policies and procedures. Administer policies and procedures according to protocol, regulatory, and lab safety policies.
• Along with the PI and Regulatory Manager, prepare and track all clinical activity documents including IRB/IBC/site registration approvals, safety reports, deviations, laboratory certifications, staff training & licenses, monitoring notices and reports, inspections & compliance, etc.
• Assist with sponsor monitoring visits remotely and onsite as needed.
• Create, maintain, and audit systems for tracking and implementing regulated activities.
• Assure the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments.
• Assist in the coordination of project activities to ensure they follow timelines and meet deadlines.
• Assist in the development of research materials.
• Perform information searches related to studies and projects.
• Provide clear and concise professional communication in response to reviewing bodies and regulatory agencies.
• Perform other responsibilities as assigned.

Qualifications

Required

• Bachelors Degree in a related field or equivalent experience
• Minimum of three years experience in clinical research with emphasis on IRBs, Ethics Committee and Human Subjects review for a pharmaceutical, biotechnology, or academic clinical research setting
• Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)
• Ability to work collaboratively and build relationships across a large organization
• Skilled in technical writing and review of scientific documents
• Excellent written and verbal communication skills including the ability to communicate clearly, succinctly and effectively over the phone and in writing
• Advanced knowledge of MS Word and Acrobat
• Skilled in the use of clinical trials and electronic document management systems

Preferred

• Five or more years of experience in in clinical research with emphasis on IRBs, Ethics Committee and Human Subjects review for a pharmaceutical, biotechnology, or academic clinical research setting
• IRB, Regulatory and/or Clinical research-related certification preferred (CIP, RAPS, ACRP, SOCRA)
• Previous experience with non-human subjects, exempt and minimal risk determinations

Fred Hutchinson Cancer Center 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, prior to their first day of employment:
Provide proof of being fully vaccinated against COVID-19 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare providers 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 $70,817 to $106,225 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).