Founded Smith Scientific LLC to provide specialized consulting services in clinical research and trial management.• Provides consulting services to pharmaceutical companies, research organizations, and sites advising on trial protocol development, deliverable creation, and patient recruitment and retention strategies.• Serves as a subject-matter expert in clinical trial enrollment success, improving patient engagement and participation rates.• Develops and leads initiatives for patient recruitment and enrollment success in clinical trials.• Acts as an advisor for clinical trial enrollment and patient retention strategies, enhancing study completion rates.• Oversee deliverable creation for clinical trials, ensuring alignment with industry standards and regulatory requirements.

As the author of 'The Ultimate Guide to Clinical Research: A Complete Handbook for Researchers and Practitioners,' I have contributed a vital resource to the clinical trials and pharmaceutical industries. This guide serves as a practical handbook for researchers, professionals, and students. I have also designed and built the accompanying website to facilitate direct access and sales.Key Experience & Responsibilities:• Authored 'A Comprehensive Guide to Clinical Research,' offering an essential resource for clinical trial professionals.• Developed and launched the website clinicaltrialshandbook.com, facilitating global sales and outreach.• Provided insights and content related to clinical research protocols, trial management, and best practices in the field.• Created a robust marketing and distribution strategy for the textbook through online platforms.

• Led a fully remote, cross-functional team of Clinical Project Managers and Coordinators to deliver mobile clinical research visits to patients.• Developed and designed tailored deliverables for specific project protocols to ensure accurate clinical data collection.• Acted as the primary client-facing liaison, building partnerships and ensuring client satisfaction.

• Clinical Research Manager of the Clinical and Translational Sciences Program at the Linda Crnic Institute for Down Syndrome. • Responsible for the overall coordination and organization of the front end clinical and translational research program for individuals with Down Syndrome; Adults and pediatric population.• Oversee several direct reports involving all clinical coordination activities, including interactions with partner clinics, research participants and their families, and collaborating studies. Handle all IRB submissions and communications for all studies. Assist in protocol development and budget applications with global partners to further Down syndrome research.

Oversaw the design, implementation, and management of clinical research projects within the Burn ICU and Outpatient Clinic, contributing to evidence-based advancements in patient care and treatment outcomes. Led multidisciplinary teams and collaborated with federal agencies and industry partners to execute complex clinical trials aimed at improving burn patient outcomes.Key Responsibilities & Achievements:• Clinical Research Oversight: Managed multiple government-sponsored clinical trials funded by the Department of Defense and BARDA, focusing on improving burn patient outcomes and validating new treatment protocols.• Protocol Compliance & Quality Improvement: Increased protocol compliance from 62% in Q3 2017 to 97% by Q2 2018 through targeted training and adherence initiatives.• Project Management: Designed and implemented prospective research studies to improve standards of care for burn and frostbite patients, leading to new treatment methodologies and improved patient recovery metrics.• Grant Acquisition: Secured a $10,000 internal grant to launch an innovative ambulation study within the Burn ICU, enhancing mobility protocols and patient recovery processes.• Stakeholder Collaboration: Built strong partnerships with pharmaceutical companies, vendors, and external collaborators to support research initiatives and facilitate study execution.• Regulatory Compliance: Maintained strict adherence to Good Clinical Practice (GCP) guidelines, managing IRB submissions, and ensuring regulatory compliance for all research activities.• Research Communication & Leadership: Led monthly research meetings, presented data findings, and incorporated feedback from multidisciplinary teams to optimize ongoing research projects.• Scientific Contributions: Authored and presented findings at national conferences, including the American Burn Association Annual Meeting, influencing practice standards and contributing to the field of burn care research.

Led the state-wide Skin Cancer Task Force, focusing on skin cancer prevention and awareness through collaboration with diverse stakeholders. Spearheaded strategic initiatives and advocacy efforts aimed at reducing skin cancer incidence.Key Responsibilities & Achievements:• Strategic Planning: Developed and implemented a comprehensive five-year cancer action plan with measurable goals and metrics to lower skin cancer rates in Colorado and nationwide.• Leadership & Operations: Managed task force operations, facilitated monthly meetings, set strategic goals, and delegated responsibilities to ensure alignment and progress.• Grant Management: Secured a $10,000 grant to fund two portable UV cameras for community outreach and education, enhancing skin cancer prevention efforts.• Stakeholder Engagement: Cultivated strong relationships with task force members, business sponsors, and government agencies (e.g., CDPHE) to promote policies and programs addressing skin cancer prevention.• Legislative Advocacy: Co-authored and supported legislation to advance sun safety education and limit tanning bed access to minors, contributing to skin cancer prevention policy at the state level.

• Provided direct patient care through nutritional consultations and routine follow-ups.• Educated patients and families in an obesity outpatient clinic regarding weight loss management.• Developed and provided patient and family nutritional training programs for epileptic patients in the Ketogenic Program.• Obtained vendor management experience by ordering and managing all nutrition samples for the inpatient and outpatient service lines.

• Provided education and training to lactating mothers on the NICU. • Developed and implemented an extensive patient identifier protocol to correctly label and verify expressed and fortified human milk in preservation of patient and family privacy laws. • Performed organization-wide training on the breast milk label verification policy and procedure.• Conducted monthly audits to assess organizational and employee compliance on the implementation of the breast milk label verification policy and procedure.• Ensured breast milk fortifiers and nutrition samples used in the human milk lab were adequately ordered and stocked for daily operation.*Recipient of Customer Service Excellence Awards multiple years (2010, 2011).

• Part-time position training a variety of clients in a multitude of situations ranging from the elderly, to cancer patients, to highly trained, elite athletes involved in the World Cup skiing circuit and cardio-endurance events. • Built trusting rapport with clients during regularly scheduled meetings and personal training sessions to discuss individual health and wellness goals.• Designed and implemented health and wellness plans for a variety of clients that ranged from smoking cessation, water hydration levels, sleep levels, and weekly exercise scheduling. • Completed regularly scheduled health and wellness appointments to track, monitor, and motivate individual clients towards achieving their short and long term goals. • Taught successful indoor cycling classes.• Athletic Trained Junior Pioneer Hockey Teams' dry-land training biweekly through their season.

Designed and executed exercise rehabilitation protocols for individuals actively undergoing cancer treatments, focusing on personalized exercise prescriptions and comprehensive data collection to evaluate the benefits of aerobic and resistance training. Collaborated on research studies investigating the cardiotoxic effects of chemotherapy and the role of exercise in mitigating adverse health outcomes for cancer patients.Key Responsibilities:• Conducted clinical trial activities assessing the impact of cardiovascular and strength training on mitigating chemotherapy-induced cardiotoxicity in cancer patients.• Delivered individualized exercise interventions for patients currently undergoing or recently completing cancer treatment, adhering to safety guidelines and tailored fitness plans.• Performed baseline and follow-up assessments to monitor patient progress, adjusting exercise prescriptions based on clinical findings and patient needs.• Developed and implemented exercise and nutrition plans to enhance patient health outcomes and quality of life during treatment and recovery.• Documented and analyzed physiological data throughout training sessions to track patient response and contribute to ongoing research publications.

• Train a variety of clients in a multitude of situations from the general student population to collegiate staff members to members of the community.• Motivate clients to exercise at their personal best through intensive group fitness classes or one-on-one exercise.• Meticulously record and track individual’s progress through regularly scheduled fitness assessments and dietary analysis to support healthy exercise and wellness goals.