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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The Cancer Immunotherapy Trials Network is a National Cancer Institute (NCI) sponsored network tasked to stimulate the conduct of early Phase I and Phase II clinical trials in the area of cancer immunotherapy. The goals are to establish a productive network of leading investigators and institutions to implement early phase cancer immunotherapy trials, design and conduct novel biologically dictated early phase trials using agents and combinations of agents to demonstrate proof-of-concept essential to proceed to Phase III pivotal trials, and provide high quality immunogenicity and biomarker data that elucidate mechanisms of response.
The network is coordinated through a Central Operations and Statistical Center (COSC), which is housed at Fred Hutchinson Cancer Research Center. The Network is supported by an NCI grant and a commitment of substantial NCI services augmented by Fred Hutchinson Cancer Research Center institutional funds as well as industry and foundation funding.
We are seeking an energetic individual with a background in clinical research for the position of Regulatory Affairs Coordinator.
The incumbent works with the Senior Regulatory Affairs Associate to ensure regulatory compliance within the CITN COSC and affiliate network and at participating clinical research sites. Job duties include:
Serve as regulatory support liaison for interdepartmental and external agencies including, but not limited to Cancer Treatment Evaluation Program (CTEP), Office for Human Research Protections (OHRP), Regulatory Affairs Branch (RAB), Food and Drug Administration (FDA), the Fred Hutchinson Cancer Research Centers Institutional Review Office, NCI Central IRB, and participating CITN site IRBs
In conjunction with Cancer Immunotherapy Trials Network (CITN) Sr. Regulatory Affairs Associate and Clinical Trial Managers, facilitate and track trial protocols through all applicable review and approval processes including, but not limited to CTEP, FDA, IRBs, RAB, and in-country agencies
Assist in ensuring that participating CITN research sites have complied with all applicable regulatory requirements of the site registration process.
Assists the Sr. Regulatory Affairs Associate in regulatory oversight on safety reporting for the CITN and CITN affiliate network
Assist in compiling materials needed for investigational new drug (IND) submissions, IND safety reports and annual reports as required
Contribute to the design, development and implementation of SOPs that ensures the CITN COSC conducts its regulatory activities in accordance with FDA/ICH regulations and guidance documents
Assist in preparing and submitting regulatory documents
Perform document filing and retrieval as directed
Contribute to departmental process improvements which impact Regulatory Affairs
Assist the Sr. Regulatory Affairs Associate in monitoring, interpreting and validating current and changing regulatory legislation and instructional polices, and ensure new regulations or changes to existing regulations are communicated throughout the CITN COSC sharing potential impacts these changes may have on ongoing protocols
Assist the Sr. Regulatory Affairs Associate in managing sites who utilize the Fred Hutch IRB as the IRB of Record
Assist the Sr. Regulatory Affairs Associate in providing review of non-lead IRB sites consent forms and other applicable regulatory documents
Coordinate with others, as appropriate, to resolve highly complex or extraordinary regulatory problems that may arise seeking assistance from appropriate internal and external resources
Work to develop and acquire required regulatory skills and knowledge with guidance from Sr. Regulatory Affairs Associate
Identify potential regulatory risks to the operational plans of the CITN COSC, and propose options to mitigate risks
Assist in monitoring government websites for misconduct by investigators in clinical trials
Additional and incidental duties related to the primary job duties described above may be required for successful execution of job performance.
Minimum BS in Life Sciences, advanced degree preferred
2-3 years of experience working within the human research regulatory environment
Current working knowledge of FDA regulations as it pertains to human research, GCP, and International Council for Harmonisation guidelines
Knowledge of clinical trial safety issues
Excellent interpersonal skills and attention to detail
Experience interacting with clinical sites regarding regulatory compliance as it pertains to human clinical research
Note: Some travel may be required for this position
We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, 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 email@example.com or by calling 206-667-4700.
At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.