Kate Weed Email & Phone Number

Minnetonka, Mn, Us

• Results and relationship-driven leader with experience driving projects from inception to launch in the medical device space• Proven communicator with the demonstrated ability to create collaborative cross-functional teams that execute and deliver on time within scope and budget• Increased operational efficiency within Clinical Affairs department by implementing processes and procedures for managing communications, budget, metric reporting, and projects• Drafted and maintained project plans, identified resource needs, created timelines and generated initial budgets as part of project scope determination.• Communicated project plans, risks, and progress to key stakeholders, project contributors, and executive staff

Minnetonka, Mn, Us

• Proactively manage project level operational aspects of assigned projects/clinical studies including management of trial timeline, budget, resources, and vendors• Provide efficient updates to executive leadership on trial progress with respect to vendor selection, project plans, trial budget, and timeline management, quality standards and risk mitigation• Conduct site management including site selection, qualification, on-site or remote monitoring, data review, site communication strategy, risk and compliance oversight, activation, budget negotiation, IRB correspondence, etc.• Gather cross-functional input and create plans to help project team produce deliverables on schedule, within scope, within budget, and to achieve deliverables• Oversee and resolve operational aspects of clinical trials in accordance with standard operating procedures (SOP), good clinical practice (GCP) such as site and vendor selection, preparing clinical trial budgets• Monitor the quality of vendor deliverables, address quality issues, and identify opportunities to improve training• Accomplishments include: Drove study-start-up activities, including development of CRFs and Medidata EDC build, drove competitive qualification of 30+ sites, contract and budget negotiations, first enrollments, and site training Supported business development through creation of process checklists and guides to streamline and unify monitoring processes, as well as drafted a monitoring handbook Drove study expansion efforts, including facilitating physician discussions, revising study materials based on feedback, and maintaining lessons learned documentation

Minnetonka, Mn, Us

• Served as site manager and study lead on randomized, post-market recurrent brain metastasis study protocol• Study management activities included leading monitoring visits, contract and budget negotiation, quarterly payment management, identifying and addressing data trends, and providing interim reports/presentations to key stakeholders• Collaborated cross-functionally to support business development, including interfacing with Product Development, Manufacturing, Sales, Marketing, Distribution, and Regulatory Affairs.• Accomplishments include: Managed study-start-up activities, including finalization of protocol, development of study plans, and creation of supporting study materials, provided additional monitoring support to meet company’s business objective, supported internal development by providing department presentations

• Conducted site assessment, initiation, periodic, and close out visits including remote review of electronic data and regulatory documents, identifying and resolving discrepancies, and performing source data verification• Identified and followed up on compliance issues, providing support and assistance to sites as needed• Trained research coordinators and physicians on study protocols and federal regulations/requirements related to clinical studies, acting as a liaison between the site and Sponsor• Accomplishments include Supported business development activities through blog writing, supported internal development through creating and revising training presentations, assigned to four protocols at various Sponsors, and assisted with onboarding of new CRAs

Golden Valley, Mn, Us

• Coordinated research projects including sponsored clinical trials, investigator-initiated studies, and medical record chart review studies• Supported informed consent process, maintained IRB continuing review applications, and conducted research in accordance with organizational and federal regulations• Worked closely with care teams, quality teams, and physicians to ensure protocol compliance• Test and evaluated data collection software application to support questionnaire validity, patient compliance, and accurate data exportation

Bloomington, Mn, Us

• Assisted with data management duties including managing databases, training staff on analysis procedures, and contributing to interobserver agreement• Supported study publications and presentations through peer review and writing manuscript and abstract content • Collaborated with behavioral scientists in the development and progression of research studies, including data collection, analysis, and interpretation

St. Paul, Minnesota, Us

Collaborated with professors to provide instruction to struggling students, assisted with daily lesson planning, provided students with constructive feedback in a timely manner, and efficiently graded reports.

St. Paul, Minnesota, Us

Managed incoming client demographics and health information, conducted one-on-one health and wellness assessments, and familiarized clients with performance threshold measurements, corrective exercises, and disease prevention.

Recruited participants, designed training periodization, and implemented workout programming for figure skating athletes. Demonstrated proper lifting mechanics and modified programming for individualized athletic development.

Implemented strength and conditioning workouts for both male and female athletes, ranging from 6th grade to college aged. Taught proper lifting techniques and skills, assisted with combine and fitness testing, and maintained a functional facility.

Bachelor Of Science (B.S.), Biokinetics: Human Bioenergetics Emphasis

Master Of Science (M.S.), Exercise Physiology