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||Seattle Cancer Care Alliance
||Seattle, WA US
|| Accounting/Auditing, Biotechnology and Pharmaceutical, Customer Service and Call Center, Finance/Economics, Healthcare, Other, Healthcare, Practitioner and Technician, Human Resources, Information Technology, Installation, Maintenance, and Repair, Executive Management, Quality Control, Research & Development, Medical
Regulatory Affairs Manager|
Seattle Cancer Care Alliance brings together the leading research teams and cancer specialists of Fred Hutch, Seattle Children's, and UW Medicine. One extraordinary group whose sole mission is the pursuit of better, longer, richer lives for our patients.
Manages the regulatory affairs for the SCCA Research Integration (RI) Program to ensure that the clinical trials initiated and/or maintained by RI are conducted in compliance with the clinical trial protocol as well as all applicable state and federal regulations. Overall responsibilities for ensuring RI trials meet regulatory requirements and are compliant with federal institutional policies. This is critical for ensuring the quality of the research, the reputation of the institution, and patient safety. Oversees regulatory policies, processes and staff for the SCCA Research Integration Program including credentialing, regulatory documentation, quality assurance and protocol compliance monitoring. Co-leads oversight of SCCA’s Human Research Protection (HRP) program and efforts to ensure that SCCA continually provides a safe and compliant environment for the conduct of human subject research. Oversees SCCA’s Protocol Compliance Monitoring program and staff to ensure that SCCA meets its commitment to timely assessment and implementation of preventative actions to achieve and maintain protocol compliance. Oversees the coordination and management of Research Integration’s QA activities associated with industry sponsored, investigator initiated and NCTN clinical research studies that include, but are not limited to, the review of all trial-related activities and documents to assure compliance with the protocol plan, internal policies, standard operating procedures (SOPs), good clinical practices (GCPs) and all other relevant regulations. Assesses staffing needs, hiring and retaining high-quality staff, completing performance evaluations in a timely fashion, taking disciplinary actions when needed, and handling the day-to-day human resources functions of the team.
- Coordinate and submit on-going regulatory documents to institutional and external IRBs. Track and report annual IRB renewals, submission of annual reviews, modifications to existing protocols, Serious Adverse Events (SAEs) and protocol deviations to the appropriate SCCA group, IRB or sponsor.
- Ensures SCCA meets its regulatory obligation for the conduct of recombinant DNA research by administratively overseeing the SCCA Institutional Biosafety Committee (IBC) and any related requirements.
- Maintain and update all required regulatory documents including but not limited to FDA Form 1572 and/or 1571, protocol signature page, Investigator Brochure (IB), financial disclosure, laboratory accreditations , laboratory reference ranges, investigators’ and research staff CVs, medical licensures, and related forms per sponsor or federal requirements.
- Maintain study-specific regulatory files and location-profile filing system per FDA guidelines.
- Oversee submission and maintenance of safety documents including Investigational Drug Brochures, IND safety reports, and SAE reports.
- Independently assess prioritization of all regulatory affairs to include protocol submissions, clinical trial regulatory maintenance, regulatory document collection, submission of protocol violations, contact of Sponsors and IRBs to ensure timely IRB approvals in addition to other tasks. Maintain knowledge of all RI-led clinical trials to ensure regulatory compliance.
- Partners with the clinical research management to analyze clinical research protocols to assess regulatory requirements and anticipate/resolve any potential regulatory issues.
- Supervises and leads quality assurance efforts in regards to research regulatory compliance.
- In collaboration with RI medical and administrative leadership, may manage and track aspects of the study selection/feasibility process for all industry-sponsored trials.
- Works with clinical research leadership and research finance on contracts, budgets and billing as needed.
- Manages communication with pharmaceutical sponsors, cooperative research groups, the IRB, FDA, NIH, NCI, CTEP, and other regulatory bodies to facilitate approval of research projects.
- Organizes, prepares, and submits periodic and annual progress reports to the FDA/NCI/ NIH/CTEP/IRB and/or other agencies as required.
- Audits current data systems to assure integrity of the system (timeliness of data entry, accuracy, reliability, and validity of the clinical research data, adherence to regulatory requirements). Takes corrective action as needed.
- Coordinates the development of investigator-initiated protocols, including: preparing drafts, managing appropriate internal reviews, implementing revisions, and version control.
- Liaison for department-wide IT initiative to improve electronic data capture, clinical trial management, and regulatory/eIRB.
- Develops and regularly reviews regulatory policies and standard operating procedures (SOPs).
- Provides leadership for regulatory staff, promotes professional growth and participation in shared decision making.
- Lead/participate in regulatory components of internal audits (including IRBs) and external audits (Sponsor/FDA) and will have responsibility for associated preparation, execution and corrective action tasks.
- Prepares and submits regulatory documentation including IND/IDE applications, annual reports, Serious Adverse Event reports, etc. to the appropriate regulatory agencies including the U.S. Food and Drug Administration (FDA).
- Oversees the development of clinical trial consent forms in accordance with CFR and FDA guidelines, ensuring all appropriate “Elements of Informed Consent”. Translate complicated research protocol requirements into language easily understandable by research participants.
- Participate in reviewing and assessing new research projects and assist investigators and RI leadership with feasibility analysis from a regulatory perspective. Lead sponsor’s qualification visits with the principal investigator.
- Responsible for overseeing the conduct of quality assurance audits of RI trials and ensuring compliance with study protocols, program SOPs, policies, GCP and FDA regulations. The QA procedures include regulatory and clinical compliance reviews of trial activities such as source document verification against data capture systems, consent documentation compliance, and AE, SAE and concomitant medication review. Prepare audit reports and present process improvements to RI leadership and internal collaborators. Develop and implement process improvements via policy and procedure development and training programs.
- Lead RI SOP development and implementation by drafting, reviewing and maintaining SOPs, policies and procedures.
- Prepare interim reports and assist with analysis.
- Work in collaboration with other Research Integration Managers and staff to execute the research mission of SCCA and support the Associate Director and Director in all RI initiatives.
Reports to the Associate Director of Research Integration and in close collaboration with the Director of Research Integration. Also works closely with other Research Integration Managers, Principal Investigators, UW/FH Research Managers, coordinators, clinical operations staff and all SCCA/FH/UW staff. Must have the flexibility and managerial commitment to work collaboratively with all study sponsors, SCCA partners and external stakeholders as applicable.
KEY KNOWLEDGE SKILLS AND ABILITIES
- Bachelor Degree and 2 years industry related experience OR Associates degree and 4 years of industry related experience
- Regulatory, CCRA or CCRP certification preferred
Minimum Leadership Experience:
- Demonstrated leadership abilities through prior work experience. Multiple years of prior direct staff supervision including staff mentoring and performance management as well as daily operations oversight strongly preferred.
Other Key Skills and Abilities:
- Computer literate to include working knowledge of Microsoft Office Programs (Word, Excel, Access and PowerPoint), E-mail applications (i.e. Microsoft Outlook), and SharePoint. Experience with Clinical Trial Management Systems (CTMS) preferred.
- Requires experience with medical terminology
- Knowledge of protocol and consent form development.
- Excellent knowledge of the regulations established by the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP), International Conference on Harmonization (ICH), and Good Clinical Practice (GCP) Guidelines.
- Experience working with Pharmaceutical Sponsors, Cooperative Groups, FDA, National Institutes of Health (NIH), National Cancer Institute (NCI), and Cancer Therapy Evaluation Program (CTEP) representatives.
- Demonstrated communication, leadership, and team building skills: evidence of this should include dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing and directing the activities of others.
- Demonstrated skill in working with minimal supervision. Effective written, verbal communication.
- Ability to manage change, promote positive interpersonal relations, and has a well-established understanding of the healthcare culture.
- Strong organizational, planning, budgeting and customer service skills.
- Must have excellent presentation, facilitation, and influencing skills.
- Self-starter with strong sense of ownership and ability to work autonomously while keeping leadership informed of progress and barriers to success.
- Excellent creative and conceptual thinking abilities.
- Ability to gather information from multiple sources in order to gain a thorough understanding of needs.
- Strong analytical and critical thinking skills.
- Ability to handle multiple tasks, deadlines and requests in an unpredictable environment while utilizing appropriate time management skills.
- Ability to innovate, develop or adopt best practices and manage through change.
- Ability to successfully navigate in complex organizational structures to complete work.
Seattle Cancer Care Alliance|
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