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Work Background
Jackson Taylor TherapeuticsCo-Founder | Clinical Research Officer
Feb. 2023Wilmington, Delaware, United StatesAn AI Genomics / Therapeutics R&D firm focused on mapping the Human Genome for People of Color to remove health disparities and commercializing therapeutics for equitable healthcare.
CR ClinicalCEO | Clinical Project Manager | Independent Clinical Research Associate | Recruiter
Jun. 2015United StatesManage US and International multi-site trials (device and pharmaceutical). Responsible for overall project performance including timelines and budget, site selection/qualification, as needed. Act as the primary interface with sponsor on all aspects of the project. Develop Project Plans, Monitoring Plans, and Risk Management Plans. Train CRAs, Principal Investigators and Site Coordinators on study plans, clinical protocols and Good Clinical Practice. Directly manages project-related activities of field and in-house CRAs, assigned to the project team. Reviews and approves monitoring visit reports and takes action as required with Sponsor and/or sites. • Delegate clinical research task to monitors and other staff
• Oversee full clinical operations for clinical trial
• Manages a project as a project manager / project lead overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
• Lead project team to ensure quality, timelines, and budget management.
• Accountable for the financial performance of each project.
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
• Accountable for all project deliverables for each project assigned
• Identify study risks, issues, and deviations then develop trainings and CAPA plans
PAREXELSenior Clinical Research Associate (Regionally Home Based)
Mar. 2014 - Jun. 2015
PAREXELClinical Research Associate II (Regionally Based, USA)
Feb. 2013 - Mar. 2014regional
CovanceClinical Research Associate (Regionally Based, USA)
Nov. 2010 - Feb. 2013• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance; liaise with vendors; and other duties, as assigned
• Responsible for aspects of registry management as prescribed in the project plans
• General On-Site Monitoring Responsibilities:
o Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
o Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
o Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
o Monitor data for missing or implausible data
o Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy
• Prepare accurate and timely trip reports
• Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management
• Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
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