Role Description Senior Biostatistician: - Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams. - Develop phase 1-4 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studies. - Review ADAM and TLFs; work with client and programmers to resolve comments. - Strong programming and logic skills (working knowledge of SAS). - Ability to apply drug development knowledge during production of high quality statistical analyses. - Perform sample size calculations for a variety of scenarios and study designs. - Lead projects (all phases and even a program of studies) and smaller submissions, manage client meetings, CRMs, collaborate well with regulatory, PMs and sponsor. - Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutic areas. - Understand the various tools that we work with. - High level knowledge of drug development as it pertains to biostatistics. - Provide support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician. - Review the statistical section of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study. Create the statistical section of the Sponsor’s protocol with minimal support. - High proficiency with MS Office applications. - Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation. - Provide ICH guideline based input as applicable to statistics. - Prepare and review statistical methods and results sections for the CSR with minimal support in collaboration with in-house medical writers. Qualifications - College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience required. - Minimum of 5 years’ experience in Biostatistics or similar field required. - Expert knowledge of scientific principles and concepts. - High level knowledge of drug development as it pertains to biostatistics; ability to apply drug development knowledge during production of high quality statistical analyses. - Strong SAS programming, SAS base, SAS macro experience. - Thorough knowledge and understanding of clinical data preferred. - Strong experience with data and production of TLGs. - Excellent scientific writing skills. - Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques. - Proficiency with MS Office applications. - Hands-on experience with clinical trial and pharmaceutical development preferred. - Good communication skills and willingness to work with others to clearly understand needs and solve problems. - Excellent problem-solving skills. - Good organizational and communication skills. - Familiarity with 21 CFR Part 11, FDA, and GCP requirements. - Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Requirements - Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.

Title: Clinical Trials Nurse Location: United States, WA Job 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 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. 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. The Clinical Trials Nurse assumes responsibility for representing Fred Hutch Clinical Operations in the review and implementation of clinical trials in the Fred Hutch ambulatory clinic and Fred Hutch Hospital. Responsibilities include providing nursing input into research protocol review process for new and modifications to existing treatment protocols, collaborating with research study teams (including Principal Investigators) and clinical service areas to identify and resolve issues, and developing educational resources for both study teams and clinical area staff. Remote Position for Washington State: Responsibilities - Reviews all new clinical research protocols and modifications to existing protocols for nursing specific implications, assesses studies for clinical operations feasibility and makes recommendations for changes as necessary. - In partnership with study team and other clinic areas, creates clinic flow for new clinical trials ensuring all protocol requirements are met. - Works in partnership with faculty investigators and study team members to prepare research protocols for enrollment and to identify and mitigate any potential operational challenges - Prepares summary of study procedures occurring in the clinical setting. - Coordinates with all relevant clinic areas to vet protocol requirements and clinic flow for new trials. - Develops study specific education plan and educational materials specific to clinical staff; delivers protocol in-service training as needed. - Informs investigators and study staff of institutional policies and procedures that support protocol compliance, patient safety and clinical operation's efficiencies. - Collaborates with Principal Investigators and study teams to resolve clinic-related barriers for protocol activation. - Works collaboratively with all members of the healthcare team. Communicates effectively with colleagues and other healthcare team members. - Supports development and maintenance of clinical trials reference materials ("Knowledge Hub"). - Supports development of research orders from drafting through approval. Qualifications MINIMUM QUALIFICATIONS: - RN with at least one year of experience in a nursing specialty relevant to the hiring department. PREFERRED QUALIFICATIONS: - Bachelors Degree in Nursing. - 3+ years of recent oncology experience. - 2+ years research experience. - Current Washington State Registered Nurse (RN) license or current NLC multistate license (MSL); and must upgrade to an MSL primary state of residence, WA, within 60 days of hire. This requirement may be waived under specific circumstances, subject to approval. - Current BLS AHA Health Provider Card (or equivalent course, such as by the American Red Cross) and renewal required every two years. - Certification in Oncology Nursing (OCN), BMTCN, AOCN, AOCN. - Active experience working with Oncology research order sets in Epic. - Demonstrated ability to work as an effective member of an interdisciplinary team. - Demonstrated skills in critical thinking and problem solving. - Demonstrated process improvement mindset. - Ability to successfully work to deadlines and targets. - Experience in the care of oncology patients. - Experience with clinical research preferred. - Proficiency with Microsoft Office applications (Word, Power Point, Excel, Outlook, Teams). - Strong written and verbal communication skills. The annual base salary range for this position is from $104,458 to $165,090, and pay offered will be based on experience and qualifications.Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.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 (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks). Additional Information We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. 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.

Title: Clinical Trial Research Assistant - Data Manager Location: Iowa City United States Job Description: The clinical trial research assistant/ data manager will be an integral member of the research team in the Institute for Clinical and Translational Science (ICTS) Coordinator Core. This position will provide research support by performing activities which are vitally important to establish the research core for the ICTS, as well as to grow and foster innovation through research support endeavors. The clinical trial research assistant/ data manager will apply clinical skills to administer, deliver, and evaluate research protocols. Duties to include but not limited to: - Perform clinical/health care research activities in various departments. - Screen, recruit, enroll and obtain informed consent for clinical research activities. - Assist in the design, development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures. - Assist patients with problems related to protocol. - Assist in the design, development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures. - Assist patients with problems related to protocol. - Manage and organize regulatory documentation. - Prepare regulatory submissions. - Conduct literature reviews and maintain citation database. - Pull data reports from qualitative data management software. - Participate in preparation of grant applications for extramural funding. - Provide assistance with tracking and reconciling grant/trial budget free balances and identify opportunities to ensure that grant funding is being used as intended and awarded. For a full job description, please send an e-mail to the contact listed below. About ICTS: The Institute for Clinical and Translational Science (ICTS) at the University of Iowa was approved by the Iowa Board of Regents in 2007 to support the work of investigators involved in clinical and translational science. Our mission is to accelerate translational science through programs to develop the translational workforce, to promote engagement of community members and other stakeholders, to promote research integration across the lifespan, and to catalyze innovative clinical and translational research. These efforts will lead to the development of novel therapies and healthcare delivery strategies, the integration of translational research and clinical practice, and, ultimately to measurable improvements in the health of Iowa and the nation. Percent of Time: 100% Pay Grade: 3A https://hr.uiowa.edu/pay/guide-pay-plans Benefits Highlights: - Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans - For more information about Why Iowa?, click here Required Qualifications - A Bachelor's degree in a Health Science field or an equivalent combination of education and research experience. - Excellent written and verbal communication skills. - Working knowledge of Good Clinical Practice (GCP) in research. - Ability to work nights and weekends. - Proficiency in Microsoft Word, Outlook and Excel. Desirable Qualifications - Basic (6 months - 1 year) of clinical research experience. - Educational background in public health or experience participating in public health research projects. - Previous experience writing manuscripts for publication. - Experience with REDCap, Epic, ICart, I-CTMS, and ACCESS. - Previous experience in data collection and entry. - Experience in processing research regulatory documents. - The ability to work independently. - Excellent time management skills and ability to perform detail-oriented work. Application Process: In order to be considered for an interview, applicants must upload the following documents and mark them as a "Relevant File" to the submission: Resume Cover Letter Job openings are posted for a minimum of 7 calendar days and may be removed from positing and filled any time after the original posting period has ended. Successful candidates will be required to self -disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.Hybrid within Iowa: This position is eligible for a combination of on-campus and remote work. Remote work must be performed at a location within the state of Iowa and comply with the remote work program and related policies. Remote within Iowa: This position is eligible for primarily remote work but may require limited work onsite at times. Remote work must be performed at a location within the state of Iowa and comply with the remote work program and related policies. As previously discussed, this position is eligible for hybrid work within Iowa and will require a work arrangement form to be completed upon the start of your employment. Per policy, work arrangements will be reviewed annually, and must comply with the remote work program and related policies and employee travel policy when working at a remote location. This position is not eligible for University sponsorship for employment authorization. Additional Information - Classification Title: Clin Trials Rsrch Asst/Data Mg - Appointment Type: Professional and Scientific - Schedule: Full-time - Work Modality Options: On Campus Compensation - Pay Level: 3A

988 Clinical Supervisor - Crisis Location: Fully Remote (Must reside in Washington State, Arizona, Ohio, or Texas) Full-Time | Multiple Shifts Available (Days, Swing, Overnight) Salary Range: $86,000-$94,000 Lead with Purpose. Support Lives in Crisis. Job Description: Every call can change a life. As a 988 Clinical Supervisor, you'll lead and support frontline crisis responders who provide compassionate, life-saving support to individuals in their most vulnerable moments. This is a hands-on leadership role for a licensed (or license-eligible) mental health professional who thrives in fast-paced environments and is driven by impact, mentorship, and service. At Crisis Connections, you'll help shape the quality of crisis care delivered across King County and Washington State-ensuring that every caller receives timely, thoughtful, and effective support. Why This Role Matters - You'll directly influence the quality of suicide prevention and crisis response services. - You'll mentor and develop crisis professionals doing emotionally demanding, meaningful work. - You'll help ensure 24/7 coverage and clinical excellence in a high-impact contact center. - You'll collaborate with clinical leaders and community partners across the state. What You'll Do - Supervise, coach, and support crisis line staff and volunteers - Provide clinical guidance and mentorship during real-time crisis situations - Support daily operations in a 24/7 crisis contact center - Train staff on best practices, policies, and crisis intervention techniques - Monitor call and performance trends to ensure quality and consistency - Partner with internal leaders and external behavioral health providers - Serve as a trusted clinical resource for staff at all experience levels Requirements What You Bring - Master's degree in Counseling, Social Work, Psychology, or a related field - Qualified as a Mental Health Professional under Washington State standards (active or license-eligible) - Licensure (or associate licensure) in counseling or social work - Experience supporting individuals in crisis - Strong communication, documentation, and computer skills - Agency Affiliated Counselor (AAC) credential required by the end of the probationary period. Applications must be submitted within 30 days of hire. Crisis Connections will reimburse the cost of obtaining the credential. Preferred - Experience with crisis lines, helplines, or phone-based assessments - Training or facilitation experience - Background in call center or multidisciplinary environments Why You'll Love Working at Crisis Connections - Comprehensive medical, dental, and vision coverage - Generous paid time off and paid holidays - Retirement and transit benefits - Ongoing training and professional development - A mission-driven, inclusive workplace committed to equity and belonging