Sakeli Hall
Senior CRA / senior Clinical Research Associate
- Role
- Cra Ii at ProSciento, Inc.
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Sakeli Hall
A Clinical Research Associate with experience in clinical, academic and industry research. Clinical experience managing/monitoring Phase clinical trials. Clinical and Industry experience with GCP/GMP/GLP compliance, study management, protocol adherence, tracking of study related documents, as well as data verification and review.
Experience
Cra Ii
Apr 2024 — Present · San Diego, CA, US
Performs site qualification, site initiation, interim monitoring, site management and closeout visits (performs on-site and remote monitoring).• Performs site management activities ensuring regulatory, ICH-GCP and/or Good Clinical Practices (GCP) and protocol compliance.• Effectively communicates/escalates serious issues to the project team and develops action plans for resolution.• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject, as required/appropriate.• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator’s site such as protocol deviations/violations and issues. Demonstrates diligence in protecting the confidentiality of each subject.• Verifies data entered into the case report forms (CRFs) is consistent with subject clinical records, electronic medical records and source data to ensure accuracy. Additionally verifying site compliance with electronic data capture requirements.• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP.• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
Education
Tougaloo College
Bachelor’s Degree, Biology
Jackson State University
Doctor of Philosophy - PhD, Environmental Science
Jackson State University
Master’s Degree, Biology
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.