Blake Barrington Email & Phone Number

Durham, North Carolina, United States

CRA I (Mar-Sep 2023)CRA II (Oct 2023 - Present)Oncology, Phase 3 (Current study: NCT04987203)- Build relationships with investigators and site staff.- Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.- Address and resolve issues at sites, including, questions, potential deficiencies in documentation, communication, and the need for additional training.- Apply working knowledge and judgment to identify and evaluate potential data quality issues. Determine and implement appropriate follow-up action with the input of other / relevant parties and / or guidance provided, if applicable.- Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.- Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.- Review site recruitment plan in collaboration with the site staff on an ongoing basis.- Perform and report on-site visits and remote contacts in accordance with the monitoring plan; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.- Assess and manage test article/study supply including supply, accountability and destruction/return status.- Review & follow-up site payment status.- Follow-up on CRF data entry, query status, and SAEs.- Conduct on-site study-specific training (if applicable).- Perform site facilities assessments- Maintains sound working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL / Sponsor training requirements and study specific procedures, plans and training. Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required.

Durham, North Carolina, United States

Research & Development, Clinical Affairs- Assist the Clinical Affairs team with study start-up activities (including, but not limited to, site selection, regulatory document collection, site qualification and initiation visit scheduling and completion, and study document packets distribution) and the ongoing conduct of studies.- Liaise with study sites and develop positive working relationships with sites, as well as conduct monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports.- Maintain engagement of Primary Investigators and study coordinators at designated sites.- Assist in drafting and revising informed consent forms (ICF), protocols, and case report forms (CRF) and other patient reported outcome (PRO) questionnaires.- Maintain electronic trial master files (eTMF), investigator site files and electronic data capture systems (EDC).- Act as a central contact for the Clinical Affairs team for designated project communications, correspondence, and documentation.o Designated principal contact/manager for StimRouter Chronic Peripheral Pain Registry (NCT03913689)- Aid the Clinical Affairs/Operations team with preparation, distribution, and maintenance of study documents.- Support with other tasks and R&D team projects as assigned.

Morrisville, North Carolina, United States

Clinical Administration & Regulatory Management team contracted with the Food & Drug Administration's (FDA) Division of Allergies, Immunology & Transplantation (DAIT)- Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.- Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.- Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads.- Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.- Provides system support (i.e. eTMF).- Supports RBM activities.- Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.- Supports scheduling of client and/or internal meetings.- Reviews and tracks local regulatory documents.- Transmits documents to client and centralized IRB/IEC.- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.- Assists with study-specific translation materials and translation QC upon request

Durham, North Carolina, United States

Pharmacovigilance and Lifecycle Safety, Phase III Clinical Trial in Nephrogenic Anemia- Analyze the needs of the customer and determine how operations can be altered in order to best meet the customer's needs. Expedite planned corrective instrument service, asset relocation, and asset management operations; and supporting field and sales operations, installation management and validation services.- Receive, triage, review and process Lifecycle Safety data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle Safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of secondary review.- Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting.- Contribute to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.- Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.- Ensure compliance to Quintiles high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables.

Durham, North Carolina

Department of Pediatrics, Division of Infectious Diseases (PI Bill Steinbach)- Supported NIH and institutionally funded studies of novel treatments for aspergillosis caused by Aspergillus fumigatus. - Facilitated, designed and carried out pre-clinical, translational drug treatment research of investigational drugs, producing data and results towards NIH-sponsored clinical trials in the United States.- Incorporated research methods not limited to formulation chemistry, cell/tissue culture, toxicity and treatment studies in invasive aspergillosis animal models, data production and analysis, Western blot, DNA/RNA extraction, project management.

Durham, North Carolina, United States

Department of Ophthalmology (PI Scott Cousins)- Supported the Duke Eye Center in assisting the Vice Chair of Research pursue both NIH-funded and industry-funded studies of various areas of dry and wet age-related macular degeneration (AMD). - Assisted in translational research of the role of circulating bone marrow-derived progenitors (stem cells) in contributing to wet AMD and attempting to develop treatments for dry macular degeneration and improving vision in eyes with wet macular degeneration. - Assisted in developing blood tests and new imaging technologies (i.e. matrigel chambers) for the identification of patients who are at high risk for progressing into complications. - Incorporated research methods not limited to formulation chemistry, cell/tissue culture, surgical procedures in animal models, angiogenesis imaging, Western blot, RNA extraction, project management, data analysis.

Durham, North Carolina, United States

Department of Surgery and Center for AIDS Research- Assisted with research into antibody dependent cellular cytotoxicity in relation to SIV/HIV infected cells. The study was in conjunction with existing vaccine studies and trials. - Duties included, but were not limited to, tissue cell culture, microscopy, cell staining, flow cytometry and efficient assay implementation.

Durham, North Carolina, United States

Division of Medical Oncology and the Department of Pharmacology & Cancer Biology (PI Chris Counter)- Served as the sole technician for a research physician, carrying out all in lab functions pertaining to his research focus.- Assisted with research into iNOS, IL-6, and causes and treatment of Ras-mediated pancreatic cancer.- Duties included, but were re not limited to, tissue cell culture, microscopy, DNA purification, cloning, PCR genotyping, blot techniques, ELISA, xenografts, necropsies, and regular animal (mouse) handling and care. - Presented for lab meetings and journal clubs.

Durham, North Carolina, United States

Duke Institute for Genome Sciences and Policy (Duke Center for Genomic and Computational Biology)- Assisted with management of financial records and reconciliation related to research grant funding for several principle investigators in IGSP. Helped prepare the department for a federal audit.

Chapel Hill, North Carolina, United States

UNC School of Medicine, Department of Microbiology and Immunology (Collins Lab)- Assisted with preparation and cultivation of growth media and microorganisms to be used in research of the functions of pMHC and other antibodies.

Chapel Hill, North Carolina, United States

UNC School of Medicine, Department of Microbiology and Immunology (Fiscus Lab) - Assisted with management, shipping and receiving, and organization of blood borne pathogen (HIV) specimens.

Chapel Hill, North Carolina, United States

UNC School of Medicine, Pediatric and Internal Medicine-Pediatric Residency Programs- Assisted with application review of prospective interns. - Organized training and rotation schedules for current residents.- Managed filing, data entry, phone calls, internet research, and other ancillary operations.

Bachelor Of Science - Bs, Biology/Biological Sciences, General

Master Of Science - Ms, Biological And Biomedical Sciences