Experience

Kolon TissueGene, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Clinical Research Associate

  • Jun 2022 - Present

  • Aid in design and preparation of clinical and analytical performance of cell and gene therapy study through intra articular injection, protocol planning, reports and data associated to the study. • Complete all activities related to the site set-up, initiation, execution and close-out osteoarthritis clinical trials including lab sample collection, follow up on lab results, ensuring imaging qualification and subject enrollment in study. • Perform Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records. • Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion • Managing, preparing, sending, tracking, and returning investigational supplies at individual sites. • Monitoring and documenting investigational product dispensing, inventory, and reconciliation. • Monitoring and documenting laboratory sample storage and shipment. • Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities • Actively involved in negotiating with various contract types (CTA, CDA, Master Agreements, etc), initiate and oversees contract origination, compliance approval, and execution. • Monitoring, reviewing and reporting all site and study regulatory documents through IRB/IBC approval process. • Conducted remote site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies. • Coordinate with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure integrity of the database. • Investigate and resolve DCR’s.



KCR

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Clinical Research Associate

  • Oct 2019 - Feb 2022

  • Supports the development of clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies. • Performed Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records. • Communicated deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and took appropriate action to prevent recurrence. • Led cross functional team in providing clinical study oversight under the supervision of the Senior Clinical Trial Manager. • Conducted remote site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies. • Provide study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines • Use of ETMF such as Veeva Vault to upload documents retrieved from my assigned clinical sites using the study specific table of content and naming convention per the TMF plan. Also, in conducting document reconciliation ensuring study essential documents in Veeva matches the documents filed in the ISF binders on the site level, and tracking expiring documents such as Medical license, GCP certificates, IRB approvals etc and requesting updated documents from the sites. • Resolved subject visit queries in trial manager and EDC. • Ensure quality of the trial master file through content (QC) review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted. • Serve as system expert and point of contact for business technologies used during the study (e.g., EDC, Investigator Portal, TMF).



LabCorp Clinical Trials

• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Research Associate

  • May 2017 - Sep 2019

  • Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems and clarifies and/or obtains changes to data as appropriate. • Perform investigative site file reconciliation: requests any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH - GCP guidelines, Standard Operating Procedures (SOPs), and sponsor requirements. • Monitored investigator sites (initially under close supervision from CRAs and Sr CRAs) to ensure compliance with project SOPs, requiring overnight travel up to 50% of the time Generated study specific documentation including monitoring trip reports, telephone contact reports, site correspondence and expense reports. • Selected specialists for support in clinical trials. • Serve as system expert and point of contact for business technologies used during the study (e.g., EDC, Investigator Portal, TMF). • Act as central point of contact for these vendors in resolving inventory or query issues. • Track escalation and closure of action items noted in the monitoring visit reports. • Resolved queries of CRF data with study site personnel. • Participate when required, in other areas of study management and staff training and contribute to continuous improvement and the review of systems and procedures as appropriate.