Rachel Dowty Mph Rn Ccrc Email & Phone Number

Greater Seattle Area

Direct cancer clinical research team and study protocol operations, coordinating closely with investigators and clinical departments. Manage study start-up, site activation, and close-out, including budgeting, contracting, staffing, and financial administration. Hire, train, and manage performance and career pathing for 7 Clinical Research and Regulatory Coordinators and Research Assistants. Selected to serve as Acting Manager then quickly promoted to Manager due to exceptional performance. PROGRAM & PROJECT MANAGEMENT LEADERSHIP* Evaluate and select trials to add to program portfolio: develop resource plan and budgets, assess clinical value of trials.* Negotiate contract details with sponsors, working with legal resources to establish trial budgets.* Develop detailed project plans for selected trials, partnering with compliance, clinical, financial, and administrative teams; review and update trial communication plans.* Plan and manage investigator-initiated studies funded by grants of up to $500K.* Oversee launch and implementation of approved trials in program portfolio.* Manage operationalization of protocols from 2D to 3D (concept to real life), including source checklists, informed consent documents, and data reporting tools. * Drive process improvement projects to ensure compliance, improve quality, increase efficiencies, and develop staff, in collaboration with Clinical Research leadership.* Collaborate with Cancer Clinical Research leaders and Clinical Research Program Director to drive strategic planning to ensure financial balance, meet investigator expectations, serve patient population, and distribute caseload.(CRC II: 2/2017-6/2017; CRC III: 7/2017-6/2018; CRC Lead 7/2018 – 2/2021; CRM: 2/2021 – present)

RELATIONSHIP MANAGEMENT * Drive and manage SWOG affiliation to conduct 30+ federal cancer studies under NCI/ NIH.* Established and developed partnerships with BioTech Sponsors and CROs to optimally implement industry clinical trials at site; work closely with investigators to open new trials to balance their research portfolios and evaluate trial feasibility.* Guide and mentor staff through continual operational and cultural changes resulting from merger with CHI Franciscan by increasing collaborative communications within the team and across the organization to enable adaptability and successful change management.CLINICAL RESEARCH COORDINATION* Worked with pharmaceutical research sponsors including Glaxo-Smith-Klein and Bristol-Myers-Squibb, as well as CROs including IQVIA, Syneos, PRA, Parexel.* Oversee and ensure compliance for studies and trials; train and mentor Study Coordinators to perform all compliance activities. * Manage compliance and reporting for National Cancer Institute site affiliation to conduct federally-sponsored oncology trials. * Complete IRB submissions and perform regulatory site file maintenance; create and maintain study source documents and consent forms; prepare for and participate in regulatory inspections and audits. * As Clinical Research Coordinator and Lead, conducted all aspects of participant recruitment, consent, screening, enrollment, and data collection for cancer trials in busy, diverse urban oncology clinic.

Bloomington, Indiana Area

Directed multiple concurrent social/behavioral projects, ensuring timelines and deliverables. Managed project budgets and allocation of funds and resources. Reported progress and results to stakeholders. Led project teams including investigators, research assistants, and vendors; facilitated project communications. Directly managed 4 research assistants. Accountable for evaluation, quality assurance, and data safety management.KEY PROJECTS* 4-Year, 10-site $1M Study of Smoking Cessation of Pregnant Women - Planned and launched project and data collection from grant through completion. - Drafted protocol, consent, and study instruments, considering research objectives and socio- economics of clinics. - Identified incentives based on diversity of culture and socio-economics of participants. - Evaluated and selected nicotine tests for study based on feasibility.* Concluded 30-Year Multi-Arm Longitudinal Research Study of Smoking Behavior and Attitudes - Project managed final stage of study: located initial participants, surveyed participants, managed data, and led project team through final data collection stage. * Developed, launched, and managed multiple additional in-person and online pilot studies.RESEARCH STUDY LEADERSHIP- Conducted study visits and informed consent discussions.- Ensured compliance with human subject protection.- Created/maintained study instruments, source documents, and regulatory site files.- Provided all staff and study site training.- Performed data tracking & management (Excel and SPSS).- Completed IRB submissions and reports throughout the life cycle of each study.

Bloomington, Indiana

Resource, tool, and web content development; training, technical assistance, and program evaluation for substance abuse prevention professionals and organizations.

Indianapolis, Indiana Area

Member of the State’s health care reform team; participated in implementation planning and the development of reports for stakeholders and funders; proposal development and federal notice interpretation.

Seattle, Wa

• Supervised operations for 30+ case managers and administrative staff providing telephonic medical case management for a national insurance carrier; tracked metrics and enforced expectations for quality and productivity; performed all aspects of interviewing, hiring, and personnel and performance management; ongoing training and change management• Implemented strategic planning initiatives and participated in identifying short and long term goals and opportunities for process improvement• Worked with employees, employers, physicians and claims adjusters to coordinate medical care, recovery, and return-to-work according to evidence-based guidelines in a complex regulatory environment

Greater Seattle Area

Master Of Public Health (M.P.H.), Public Health Administration

Bachelor Of Science, Nursing