Caitlin Thys Calnon, Mph Email & Phone Number

Chapel Hill, Nc, Us

United States

North Carolina, United States

• Assists in the development and management of adherence to Clinical Operations Quality Management Plans (QMPs)• Conducts document review to verify selected study documents are complete and correct• Identify need and manage implementation of process and efficiency improvement• Assists clinical team in preparing for external audits• Assists clinical team by providing input into the generation of timely and appropriate audit responses• Develops and maintain departmental training reports and metrics• Assists and train on the implementation of new training technologies and systems• Works with clinical department heads to establish and review department specific training matrices/curriculums• Maintains and facilitate the distribution, review, approval and training on Clinical SOPs• Assists with the development and delivery of training related to Clinical SOPs and processes• Manages and deliver vendor training• Collaborates with international counterparts to ensure global consistency with Inspection Readiness, Quality Management Plans and QC visits • Collaborates with management to ensure staff are adequately trained on findings from quality assessments• Collaborates with Clinical Senior Management on the development and conduct of the Quality Management Plan and Quality Control Visits • Collaborates with GCP Compliance/QA to identify trends from quality assurance site audits, and make recommendations to Clinical management to improve overall findings • Cultivates and builds relationships with key internal partners• Interacts effectively and professionally with regulatory agencies, consultants, vendors, contractors and others as required • Interacts with clinical site staff conducting clinical activities on behalf of UT

Durham, North Carolina

• Provided project consultation services to define work scope, required resources, and targeted deliverables.• Drafted project proposals/plans according to project management methodology and input from School of Medicine Leadership and key stakeholders.• Planned, lead and facilitated regular cross-functional and/or multi-unit project team meetings ensuring the team is on task and meeting objectives.• Developed communication and change management plans with project teams and the School of Medicine Dean’s Office.• Developed and maintained the SharePoint site for Duke School of Medicine NIH Grant Administration Guidance• Duke Research Administration Academy certification, in progress

Raleigh-Durham, North Carolina Area

• Coordinated day-to-day operations for all research projects for the organization using lean methodologies.• Coordinated and facilitated communication between various entities including principle investigators, CRCs, internal management and donor families. Communication avenues include face-to-face meetings, in-services, community presentations, webinars, conference calls and email. • Lead quarterly meetings with internal research committee and delivers high-level recommendations to executive leadership for strategies to improve efficiency and ensure policy compliance. • Prepared monthly reports of projects metrics for quality review board and upper management.• Developed project work flows and communication tools for concurrent projects and implemented process improvement initiatives. Awarded National 3rd Place Quality Improvement Project Award, Association of Organ Procurement Organizations, for project to improve and streamline internal research communication.• Reviewed and modified Memorandums of Understanding, Confidentiality Disclosure Agreements and Data Use Agreement for research projects.• Worked with Materials Management and Finance to provide budget justifications to external Investigators.• Performed quarterly review of budget reports to ensure compliance and identify errors• Lean 101 trained. Tools include: Process flows, Gemba Walk, A3, 5S, PDSA, Fishbone.• Performed surgical recovery of organs intended for research purposes.• Certified Clinical Transplant Preservationist through the American Board for Transplant Certification.• Trained to be a new staff preceptor

• Coordinated and managed clinical trials for Nephrology Division with medical staff, industry and academic institutions.• Managed multi-center NIH-funded Systolic Blood Pressure Intervention Trial (SPRINT).• Managed multi-center industry-funded renal transplant immunosuppression study.• Recruited and interviewed study participants.• Performed EKGs, blood draws and cognitive assessments per study protocol.• Created source documents, maintained reports and met with monitors on routine site visits.• Authored RO1 grant applications.• Provided budget justifications to funding sources.• Performed QA/QC procedures.• Mentored and trained graduate assistants and interns.

Assisted study coordinators with various elements and data collection of multiple clinical trialsAnalyzed data and submitted abstracts for review regarding cardiovascular disease risk factor study of over 200 undergraduate students. Abstract was accepted for poster presentation at the American Society of Nephrology Conference in November 2012.

• Taught Health 1000: Health In Modern Society to undergraduate students at East Carolina University with course content focused on mental, social and physical health topics related to one’s internal and external environments.• Tutored students with the completion of homework assignments and examination preparation, held office hours and provided teaching points and resources for additional help.• Created course syllabus, managed the completion of extracurricular enrichment activities, graded assignments and examinations and provided final course grades.

Greenville, Nc

• Assisted research coordinators with the management of clinical trials within the Division of Nephrology.• Analyzed data using SPSS software for cardiovascular disease risk factor study among undergraduate students at East Carolina University.• Prepared, edited and reviewed abstracts for submission to various professional meetings• Abstract accepted for poster presentation at the American Society of Nephrology Conference in November 2012.• Collected data from patient visits and prepared source documentation for sponsor’s clinical report forms.• Recruited and interviewed study participants.• Identified study subjects by screening medical records.

Rosales Arguello, Leon, Nicaragua And Greenville, Nc

• Created and maintained patient database using File Maker Pro.• Translated medical records from Spanish to English and entered patient-data into database from six previous years.• Entered patient data from adult and pediatric cardiology clinics in real time while in Leon, Nicaragua.• Received induction into East Carolina University’s Servire Society for my work in this internship.

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

Activities and Societies: Institute for Healthcare Improvement Open School Member; Institute for Healthcare Improvement Open School.

Certificate, Certified Nursing Assistant I

Certificate, Certified Nursing Assistant Ii

Bachelor Of Science (B.S.), Pre-Health Professions

Activities and Societies: Student Athlete Advisory Committee, East Carolina University; Minority Equity Committee, East Carolina.

Biology, General

Activities and Societies: Student Athlete Advisory Committee; Student Athlete Advisory Committee, Student Government Representative.

Education record