Kylee Blatchford Email & Phone Number

Denver, Colorado, United States

Senior Oncology Clinical Research Coordinator overseeing the daily execution of complex clinical studies, ensuring compliance with protocols, regulatory mandates, and company goals while maintaining a strong understanding of GCP, ICH, and FDA guidelines and industry standards. Proactively identify and resolve challenges to secure the success of clinical trials for multiple cancer diagnoses including leukemia, lymphoma, CNS, breast, pancreatic, pulmonary, bone, and other diseases.* Increased trial enrollment by 75% in the first year of hire and currently spearheading the renewal of research activities at a low accruing clinic by contributing to the improvement of subject recruitment and retention strategies.* Screen and assess the health history of 50+ potential clinic patients daily for protocol and registry trial availability and maintain multiple tracking systems related to study metrics.* Initiate program level inspection readiness plans in preparation for and defense of regulatory filings. Manage study documentation including the Trial Master File (TMF) to ensure compliance with regulations and Good Clinical Practices. Directed an internal review and reconciliation of records and standard operating procedures (SOPs) to foster growth.* Develop, nurture, and advance relationships with cross-functional teams to ensure the achievement of site operational objectives and drive site performance. Implemented weekly huddles and created electronic memos to open clear routes of communication and transparency and establish a research reporting hierarchy structure.* Coordinate and monitor site initiation visits (SIVs), study start up activities, and delegation and training of new research staff in conjunction with sponsors and vendor systems.* Control study device allocation and perform Investigative Product (IP) accountability, ensuring all pharmacy, lab, and research staff adhere to the product manual including inventory, storage, and security protocols.

Aurora, Colorado, United States

Clinical Research Coordinator III for breast and phase 1 oncology clinical trials in a university teaching hospital setting. Management of study start up, site initiation visits, amendment training, new hire interviews and training, and internal efficiency monitoring.* Responsible for all aspects of clinical trial activities and patient development including eligibility review, informed consent administration, study timepoint scheduling, medical evaluation and safety events, Electrocardiogram (EKG) and phlebotomy testing, investigational product (IP) distribution, budget and billing timelines, and treatment plans.* Work in partnership with oncology physicians to reconcile adverse event and concomitant medication reports and administer RECIST, Lugano, or Deauville assessments to evaluate patient response and efficacy of treatment.* Supervise data managers and research coordinators. Led a committee to implement a system for patient tracking and data transfer between coordinators to ensure adherence to protocols and reporting in a timely fashion.* Audit previous and ongoing research activities to ensure data compliance. Performed an in-depth review of 5 years’ worth of previous research practices and documentation as part of an overarching initiative to verify study findings.

Aurora, Colorado, United States

Clinical Research Data Manager for 40+ study trials responsible for the abstraction and recording of all subject data onto protocol-specific Case Report Forms and into cancer databases using an advanced knowledge of data collection and cleaning best practices. Act as primary point of contact between clinics and sponsors, monitors, and clinical research organizations.* Serve as the data subject expert on cross-functional teams, ensuring data integrity throughout the trial life cycle while retaining a detailed knowledge of databases, electronic health records, protocol requirements, and administrative claims data and metrics. Created & developed catered electronic Case Report Forms (eCRFs) for new protocol studies.* Develop improved comprehensive training materials, SOP guidelines, and list templates to assist and mentor new Data Coordinators while personally training teammates on query resolution techniques and best practices.* Review study documents to verify source data and appropriate data capture into electronic Case Report Forms (eCRFs) to guarantee data integrity and preparedness for regulatory inspection. Executed and distributed data management reports to the research team to encourage growth and productivity.* Recruited teammates to participate in a project to archive and digitize source documents to transition to paperless research models. Inspected and translated over 10 years’ worth of previous research source documents and data into electronic databases while maintaining current day to day operations.

Boulder, Co

* Triage patient psycho-social needs and barriers to care including recognizing high health care utilization and serving as physician clinic liaison between primary care, therapists, and specialists. * Collaborate with care team to reduce unwarranted and high cost care by providing health education, community resources, and financial tools to at-risk, chronic, and acute care patients. * Track patients’ chronic medical issues within Boulder Community Health and external health organizations and implement plan of care including immunizations, screenings, etc.* Maintain patient preventive care and chronic disease registries. * Update patient health records, clinical information, and gaps in care using Greenway and Meditech electronic medical record systems. * Facilitate in patient transition of care from hospitals, emergency and urgent care rooms, and skilled nursing facilities through follow up calls and medication reconciliation. * Act as point person for referral networks within Boulder Community Health and the community. * Maintain an up to date community resource directory and serve with the Quality and Population Health teams for outreach campaigns. * Administer diabetic retinopathy testing using Welch Allyn RetinaVue scanner and assist with group diabetes information sessions.

Seattle, Washington, United States

* Serve as point of contact for medical providers, patients and family members, surgery center, and referral clinics for pre-operative planning, hospitalizations, diagnostic testing, and post-operative care. * Provide direct support to Therapeutic Gastroenterology physician including clinic and endoscopy management, patient medical history and vitals, scheduling, and ongoing patient treatment. * Research each patient to obtain an accurate health history and gather medical treatment documents to ensure a complete record is present before point of care. * Initiate and implement procedure updates and clinic policies to reflect a growing gastroenterology practice. * Liaise with insurance providers and networks for authorization and verification of benefits and eligibility.

Sioux City, Iowa Area

* Process over 1000 patient accounts on a weekly basis for a multi-physician orthopedic surgery practice. * Schedule patient appointments and collect patient demographic information and insurance authorizations including Medicare and Medicaid in accordance with HIPPA guidelines. * Assemble and file patient charts and records and enter surgery information to be included in patient dictation. * Monitor and complete time sensitive documents related to patient ongoing care and distribute records as needed by partner health organizations. * Operate multi-line phone system and direct calls to appropriate medical personnel.

Howard Lake, Minnesota, United States

* Manage customer accounts as the Customer Service Representative, including accounts payable and receivable, purchase orders, invoices, billing statements, and office schedules, reporting directly to the CFO. * Coordinate travel arrangements and the company calendar and meeting schedule using Microsoft Outlook. * Act as Logistics and Shipping/Receiving Manager, coordinating transportation for multiple loads per week. * Handle all purchase ordering, including supplies for the office, 40+ employee production facility, and $200,000 warehouse inventory while maintaining a strict budget. * Utilize Microsoft PowerPoint and Publisher to create brochures and customer proposals and update website. * Formulated all start-up documentation for new egg distribution company including mission statements, policies, databases, recording sheets, schedules, and inventory using Microsoft Word, Excel, and Access. * Wrote and implemented SQF (Safe Quality Food) Level III and HACCP food safety plans, created food safety and regulation documentation, worked with all employees to ensure clean food practices in compliance with all FDA / USDA / OSHA / industry stipulations.

Lodge Grass, Montana

* Led outreach trips for junior high and high school students each week on the Crow Indian Reservation. * Served as a link between Crow community members and visiting groups while performing service projects including construction and home repair and children’s programs. * Coordinated evening activities, supervised daily service projects, and encouraged interaction and appreciation of diverse peoples and cultures while serving closely with three other YouthWorks team members. * Gave nightly talks to the large outreach groups concerning the setting and context of service.

Bachelor'S Degree, Global Studies (International Relations Emphasis), French Minor

French Studies, French Studies

Studied university courses in the French language. Researched the International Committee of the Red Cross for senior thesis

Education record