Christopher Crumbley Email & Phone Number

Asheville, Nc, Us

Knoxville, Tennessee, United States

Completed 1200+ hours of supervised practice in medical nutrition therapy, food service management, and community nutrition. Rotations included: clinical staff relief (UT Medical Center), pediatrics (Tennessee Children’s Hospital), renal (Fresenius), food service management (UT Medical Center), gastrointestinal/bariatrics (Integrative Nutrition Solutions and Tennova Bariatric Surgery), WIC (Knox County Health Department), extension (UT Ag Campus), and many more.

Knoxville, Tennessee, United States

Assist with syllabus development. Provide students with well-defined course objectives. Provide academic instruction and support to students in all online sections. Assist with developing teaching materials. Grade assignments, quizzes, exams, and utilize technology-based tracking and platforms of Canvas and Great River Learning. Provide weekly announcements via Canvas platform for assignment reminders, tips, and troubleshooting. Provide in-class instructions and answer questions for the anthropometric laboratory each semester. Mentor new graduate teaching assistants.

Knoxville, Tennessee, United States

Manage clinical and administrative portions of research trials utilizing over-the-counter herbal supplements to determine efficacy in the reduction of inflammation in peripheral artery disease patients undergoing stent placements. Ensure scientific integrity of data and protect rights, safety, and well-being of patients enrolled in clinical trials. Discuss study protocol with patients and verify the informed consent documentation. Meet with patients each visit and maintain accessibility to discuss any questions/concerns regarding the study. Dispense study medication in a professional and accountable manner following protocol requirements. Schedule all patient research visits and procedures consistent with protocol requirements. Complete and maintain source documents per FDA guidelines. Compare source documents with patients’ medical records for completeness and accuracy. Ensure that non-serious and serious adverse events are properly documented and reported. Recruit, train and manage volunteer staff.

Knoxville, Tennessee, United States

Assisted Gatorade Manager in executing the Gatorade summer program at the University of Tennessee. Recruited team leaders. Delivered keynote/athlete message on the first day of each camp. Assisted Gatorade Manager in managing the entire staff of team leaders on campus. Managed the shipping and receiving of all Gatorade summer camp items. Managed the allocation and distribution of Gatorade products and premiums. Assisted in the evaluation of the Gatorade program. Maintained direct communication with Paragon. Escalated issues to Paragon as they arose that affected Gatorade’s involvement in summer sports camps. Provided ongoing evaluation of camp program.

Rockville, Maryland, United States

Supervised junior data managers, served as the mentor for incoming data managers, and trained clinical research associates on data management processes. Managed development logistics of clinical protocols, wrote sections of protocols, conducted literature searches, edited and circulated copies of clinical protocols, coordinated calls between Emmes, clinical site, and the sponsor. Provided scientific and technical expertise to the director, study teams, and information technology staff. Assessed data quality by internal audits, reviewing data sets from clinical trials to address inconsistencies and protocol deviations. Ensured timely submission of documents to investigators, and regulatory bodies. Assisted in the complete research protocol development lifecycle including DCF development, ICF review, write and QC DSMB/SMC, CSRs, and ad hoc reports

Wilmington, North Carolina, United States

Lead development of clinical study design and specification documentation to support efficient database build/UAT. Lead development of clinical study edit check specification documentation to support efficient edit check programming/UAT. Lead/participated in development of complex database modification request specifications, as determined by the DM Global Teams. Consult with Clinical Data Manager and Database Programmers during clinical database start-up process on design/specification questions. Understand and followed departmental and corporate WPDs and SOPs and contributed to their development as needed

Regional

Responsible for writing and distributing time sensitive site visit reports, tracking resolutions of outstanding issues, and ensuring compliance with regulatory requirements, ICH guidelines, Standard Operating Procedures (SOPs), the study protocol and overall research objectives. Participates in protocol review calls with participating sites and prepares resulting summaries. Reviews regulatory documents. Review includes assessment of completeness and compliance with regulatory requirements. Conduct training sessions if necessary for new site personnel on GCP and study protocol requirements. Attends and participates in project and functional area meetings and continuing education. Communicates and coordinates effectively with internal and external clients and colleagues. Assigned to Phase I trials in vaccine development. Developed Clinical Monitoring Plan for assigned projects.

Aurora, Colorado

Responsible for enlisting, maintaining and assuring protocol compliance for all patients on multiple assigned clinical trials. Collaborates with physicians in determining eligibility of patients for Phase II-III clinical trials. Provides education to patients, and performs certain non-medical assessments, blood draws and ECGs. Coordinates patient care in compliance with the specific protocol requirements. Prepares documents necessary to perform the study visits and collect the required data.

Wilmington, North Carolina Area

Acted as a Lead Clinical Data Manager for one or more projects, also provided support to another Lead Clinical Data Manager for one or more projects. Liaised with clients and colleagues in other functional groups as required. Fulfilled all data management cleaning activities in accordance with the Data Validation Manual (DVM) and/or client documentation. Designated tasks appropriately within the team ensuring all work conducted is completed to the acceptable quality in accordance with global Standard Operating Procedures (SOPs) and the DVM. Represented Clinical Data Management at internal and external meetings and presentations.

Responsible for enlisting, maintaining and assuring protocol compliance for all patients on multiple assigned clinical trials. Collaborated with physicians in determining eligibility of patients for Phase II-III clinical trials. Provided education to patients, and performed certain non-medical assessments, blood draws and ECGs. Coordinated patient care in compliance with the specific protocol requirements. Prepared documents necessary to perform the study visits and collect the required data.

Managed end-to-end delivery of data management services for single/multi-service Phase III projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provided comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provided leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. Performed role of Data Team Lead (DTL), Program Lead, and/or a leadership role in a specific CDM task (e.g. Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Managed and coordinated all activities related to the design and release of the clinical study database from study concept to database lock. These activities included creation of data management plans, definition and validation of edit checks, standardization of database table structure and code lists, all coding for the entire study, blind and unblinded database reviews, queries and data reconciliation, in order to meet project requirements and timelines. Collaborated and coordinated with study team members to assist in the design, review and implementation of high quality clinical protocols and data collection systems with emphasis in exploratory development (Phase 1 and 2). Developed systems for organizing data to analyze, identify and report data and trends. Assisted with development, training and implementation of in house DM SOPs, guidelines and standards to ensure consistent and constant interpretation of data. Designed online case report forms for an EDC data management system. Created Data Validation Specifications for EDC data management system. Created eCRF completion instructions. Tracked eCRF status and queries for all studies.

Master Of Science - Ms

Activities and Societies: Graduate Nutrition Student Association, Gama Beta Phi Honor Society

Bachelor Of Science - Bs, Health And Human Services

Activities and Societies: Undergraduate Nutrition Student Association, Gama Beta Phi Honor Society, Healthy Kids Club

Bachelor Of Science (B.S.), Biological And Physical Sciences

Activities and Societies: Beta Beta Beta - Biological Honors Fraternity