Clinical Research Associate
Resume:
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Destiny Pratt, B.S. Cellular/ Molecular Biology
In-House Clinical Research Associate
Education
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Biology
School
Appalachian State University
Professional Experience
(May 2024 – Present) In-House Clinical Research Associate Rho, Inc., Chapel Hill, NC
• Assist Lead CRAs with investigative site recruitment and in-house site management activities in accordance with the Sponsor, protocol, standard operating procedures, ICH/GCP guidelines, and all applicable regulatory requirements.
• Work with the project manager, Lead CRA and travelling CRAs on a clinical trial to ensure that monitoring activities are properly supported and that critical documents are being tracked, collected, and reviewed.
• Maintain the clinical trials management system (CTMS) and other project tracking tools.
• Manage the study Trial Master File (TMF) and ensure periodic TMF audits.
• Collect, track, and review all site regulatory documents.
• Assist with development and review of Informed Consent Forms.
• Collect, track, and review investigational site records relating to subject screening and enrollment.
• Assist in the development of study plans and status reports.
• Interact with sites, clients, vendors and internal study team members.
• Track study supplies and coordinate shipments of supplies to sites as needed.
• Ensure site compliance with FDA regulations, protocol, GCP/ICH guidelines, and sponsor requirements.
• Coordinate work with CRAs monitoring on-site.
• Perform on site co-monitoring and remote monitoring activities.
• Perform regular reviews of data entered by investigational site staff according to data review/monitoring guidelines.
• Support Study Start- up activities i.e. Review, tracking of site essential documents for site activation, site communication and completion of Study start-up checklists.
(Apr 2022 – May 2024) Clinical Trial Assistant
ICON, PLC., Raleigh, NC
• Support projects related to improvement/implementation of clinical processes, systems (vendor user access and quarterly reviews), TMF QC, study supply management/shipping, reconciliation tasks and creating various study reports.
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• Ensure maintenance activities are on track and support study deliverables.
• Maintain inspection readiness of the eTMF by tracking and organizing clinical study documents (i.e. Main study files, FDFs, CRFs, etc.).
• Ensure ongoing and timely updates of documents filing into TMF systems. Assess document quality to ensure documents are efficiently uploaded.
• Serve as primary contact for the clinical team for all designated project communications, correspondence, and associated documentation.
• Support the clinical trial team on all administrative tasks such as training matrixes, agenda creation/minute documentation, the creation/maintenance of trackers, vendor access for site/study staff, communication with sites to collect study documents.
• Manage CTMS and update staff/study information, perform quarterly reviews, support regular CTMS clean up initiatives, compile study data into concise reports and other ad hoc tasks.
• Training lead for onboarding clinical trial assistants
(Sep 2021 – Apr 2022) Human Resource Assistant
USPS HR Shared Resource Center, Greensboro, NC
• Process, update, and maintain personnel transactions in support of the administration of human resources.
• Routine quality assurance review.
• Research and resolve issues associated with personnel activities and programs.
• Calculating employee salaries and compensation bonuses.
• Support human resource programs by processing transactions in the following areas: personnel actions, compensation and benefits, selection, job bidding, reassignments, staffing and/or complement management.
(Dec 2019 – Jun 2020) Technologist Trainee
LabCorp, Burlington, NC
• Extract and test blood plasma and urine samples for infectious disease.
• Perform molecular biological techniques, complete enzyme immunoassays using the Tigris and Cobas systems (e.g fluorescent antibody procedures and nucleic acid testing procedures).
• Prepared buffers and reagents for laboratory processes.
• Assist in internal and external audits from governing bodies including QA Department, FDA and German Health Society.
• Responsible for accurate interpretation, review, and release of results by utilizing the Laboratory Information Management System for sample/result documentation and tracking.
• Receive and sorted clinical lab specimens, as well as prepared specimens for testing and analysis. Followed by scanning and entering data of specimen/patient information.
• Ensure all lab equipment is working properly and perform minor instrumentation maintenance and reviews as well as troubleshoot any specimen related issues.
• Maintained a clean and safe work environment.
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• Identify instances that may have adversely affected test performance and take action to correct them with the minimal disruption to the laboratory.
• Complete record logs and other administrative duties as requested.
• Follow all SOPs and laboratory guidelines to ensure safety and quality standards are met.
Therapeutic Area Experience
• Menopause-related Endocrinology (Phase IIa): Vasomotor Systems
• Rare Disease (Phase III): Hereditary Angiodema
• Oncology (Phase III): Myeloma
• Oncology (Phase 1B/II): NSCLC
• Oncology (Phase II): Non-Hodgkin Lymphoma
• Menopause-related Endocrinology (Phase III): Vasomotor Systems
• Oncology (Phase I): Pancreatic Ductal Adenocarcinoma
• Oncology (Phase I/II): Hepatocellular Carcinoma
• Oncology (Phase I/II): Metastatic Prostate Cancer
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