The Seattle Cancer Care Alliance (SCCA), located in Seattle, Washington, is part of a dynamic collaboration among three organizations known nationally and internationally for their patient care and research: Fred Hutchinson Cancer Research Center, University of Washington, and Seattle Children's. Over the past 25 years, these institutions have worked together to support their mission of adult and pediatric oncology patient care services, research and education.
The Research Regulatory Coordinator is responsible for overseeing the day-to-day regulatory management of clinical research trials, which include phases I-IV industry, investigator-initiated, and NIH sponsored research studies, and other research projects offered through Research Integration (RI). The role is responsible for ensuring that all such clinical research activity meets regulatory requirements and is compliant with all federal, state, local and institutional policies. The position will manage study start-up, modification submissions, annual/continuous reporting, and study closeout submissions to the Institutional Review Board (IRB) and any other relevant regulatory agencies, committees, the sponsor, funding foundation or governmental agency. Preparation, submission, and maintenance of the regulatory data will require compliance with complex regulations, policies, and procedures regarding the conduct of clinical trials. This is critical for ensuring patient safety, quality of the research and the reputation of the institution. The Research Regulatory Coordinator serves as a liaison to administrative and clinical staff and must serve as a role model as they promote the mission, values, and philosophy of the Seattle Cancer Care Alliance as they perform their duties.
This position reports to the Regulatory Affairs Manager of Research Integration and must maintain effective working relationships with investigators, management and research staff (both internal and external to the organization).
Understanding of Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Code of Federal Regulations (CFR), and Good Clinical Practice (GCP) policies and guidelines as they relate to the conduct of human clinical trials.
Understanding of the research protocols and the ability to translate research requirements into appropriate regulatory actions.
Preparation, maintenance and continual oversight of all SCCA RI research-related regulatory documents, which includes, but may not be limited to, the following:
Coordinating and managing the regulatory documents from each participating Network Affiliate member institution, from each SCCA Community site location and from Fred Hutch/UW Cancer Consortium Disease Site Research Programs and service areas which are partnering with Research Integration to conduct clinical trials.
Creating and maintaining up to date regulatory documents and files at all times. Such files include, but may not be limited to, NCTN study documentation, DOA logs, Curriculum Vitae (CVs), Medical Licenses (MLs), HSP and GCP training documentation, protocol-specific training documentation, conflict of interest (COI) and financial disclosure (FD) documents, etc.
Assisting in the development and maintenance of, and adherence to, SCCA RIs Standard Operating Procedures (SOPs) and Work Instructions.
Maintaining all regulatory documentation, site documents and study regulatory files, ensuring that all documentation is compliant with all applicable SOPs and are in audit-ready condition (i.e., up to date, accurate and complete at all times).
Archiving clinical trial documents/records, ensuring that all regulatory files are prepared for off-site storage in accordance with FDA, other applicable regulatory guidelines and RI SOPs.
Coordinating and negotiating with study sponsors regarding the development and modification of consent form language; write clinical research trial consent forms in accordance with GCP and FDA guidelines; translate complicated research protocol requirements into language easily understood by research participants and laypersons.
Understanding of and the ability to perform the administrative requirements of clinical research projects.
Management of clinical research regulatory information in the Clinical Trial Management System (CTMS).
Management of record retention, archiving, and document destruction of clinical trial records, ensuring that all essential documents are handled in accordance with FDA, other applicable regulatory guidelines and SOPs.
Preparation of all submissions and query responses in a timely manner to the Institutional Review Board (IRB) to assure the protection of human subjects in research; FDA-required submissions which may include investigator 1572 forms, safety reports, and other documents that may be required by a regulatory agency or the institution. All submissions must be reviewed by the Principal Investigator (PI), be complete and accurate, and transmitted to the appropriate authority in a timely manner to meet all deadlines.
Completion of study start-up regulatory activities, ongoing IRB continuing reviews, modifications and study closeout regulatory documents with submissions to all appropriate committees and authorities. All submissions must be reviewed by the PI, be complete and accurate and be transmitted to the appropriate authority in a timely manner to meet all deadlines.
Effective communication regarding sponsor (and other committees as appropriate) queries based on regulatory submissions. Ability to determine when documentation needs to be reviewed/approved by PI. All submissions must be reviewed by the PI (if applicable), be complete and accurate, and be transmitted to the appropriate authority in a timely manner to meet all deadlines.
Management, communication and documentation of all non-compliance/deviation reports, SAEs and 3rd Party Safety Reports, ensuring that the IRB Reporting Policy is adhered to at all times. Ability to determine if information needs to be reported to the IRB, sponsor, FDA, or other regulatory authorities and whether expedited reporting criteria have been met.
Preparation for internal and external inspections, audits and monitoring visits by:
Collaborating with the QA Specialist and clinical research coordinators to prepare regulatory binders and documents.
Confirming the accuracy of the content of the regulatory binders prior to monitoring visits.
Coordination and scheduling of the monitoring visit and communicating with the monitor during their visits.
Collaboration with the QA Specialist and study coordinators to ensure completion of follow-up action items.
Bachelors degree or equivalent professional experience.
A minimum of 3 years relevant experience in oncology quality assurance, regulatory affairs, or clinical research/study coordination function
Experience in meeting FDA, GCP, ICH policies and guidelines as well as other federal, state and local regulations for research administration
Understanding of theoretical objectives of clinical research projects
Strong interpersonal skills and ability to act as a liaison with institutional faculty, administrators, industry sponsors and regulatory agencies
Ability to be flexible, multitask and switch priorities as well as work comfortably in a deadline driven environment
Effective written, verbal communication skills including presentation skills
Ability to act as a liaison between internal and external stakeholders
Ability to collaborate effectively with others
Strong attention to detail, ability to solve complex problems and ability to critically analyze complicated regulatory information to maintain compliance to applicable regulations, policies and procedures
Knowledge of medical and clinical research terminology
Ability to prioritize assignments by meeting routine and unexpected deadlines; effectively set priorities and schedule workflow required to support project, department or organizational goals
Ability to organize, plan, and implement services as well as handle multiple projects/problems simultaneously
Ability to work independently under administrative direction
Significant computer experience and competency including intermediate to advance skills in Microsoft Office programs (Outlook, Word, Excel, Access, PowerPoint and Visio). Ability and openness to learn and become proficient with new software and web interfaces quickly and efficiently
Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to do so
Knowledge of Seattle Cancer Care Alliance/University of Washington/Fred Hutchinson Cancer Research Center regulatory processes.
Experience with WIRB
ACRP or SoCRA certification (or professional certification in a related field, such as Regulatory, QA, or Clinical Research)
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 firstname.lastname@example.org or by calling 206-667-4700.
The Seattle Cancer Care Alliance was incorporated in 1998 as a separate, jointly governed non-profit that included the cancer programs of three partners. Seattle Cancer Care Alliance is a cancer treatment center that unites doctors from Fred Hutchison Cancer Research Center, University of Washington Medical Center, and Seattle Children’s. The purpose of this organization is to provide state-of the-art patient and family centered care; support the conduct of cancer clinical research and education; enhance access to improved cancer interventions; and advance the standard of cancer care regionally and beyond. The Seattle Cancer Care Alliance is the only NCI-designated comprehensive cancer center in the Northwest, and according to the National Cancer Data Base, Seattle Cancer Care Alliance patients in general have better survival rates than patients treated at other cancer treatment centers.