Technical Skills: MS Word, Excel, Outlook, Lync, and PowerPoint; Working Knowledge of Autodesk AutoCAD; Working Knowledge of MATLAB; IBM SPSS; STATISTICA; GRAPHIC STATE; OriginLab; ImageJ; Any-Maze; ARIBA; TIME; Learning Management Systems; WebEx; CONCUR; Clinical Trial Management Systems (CTMS): BRAIN; IMPACT Harmony; Forest Laboratories CTMS; iMedidata; Pedagogue; eMVR; EVRETT; IMPACT MySite; Electronic Data Capture (EDC): DataLabs; Advantage; iMedNet; INFORM (versions 4.0-6.0); BRAIN; Forest Research Institute (FRI) proprietary EDC; Medidata Rave; | IWRS/IVRS: ClinPhone; Premier i360; Bioclinica Trident Additional Skills: Undergraduate/Graduate-level Teaching Experience; Project Management; Excellent Written and Oral Communicator; Federal/Private Grant and Protocol Writing/Review; Data Production, Representation, and Analysis; Proficient/Avid Biomedical Research Journal Reader |
- Contract Senior Regional Site Manager (RSM) for Allergan and subsidiaries, including Forest Research Institute (FRI) and Actavis PLC, through Planet Pharma Staffing;
- Demonstrated strong knowledge, understanding, and application of monitoring SOPs and Good Clinical Practice to ensure protocol and regulatory compliance across studies and site assignments;
- Employed Risk Based Monitoring (RBM) on a daily basis to assess and improve site performance and minimize key risk indicators per sponsor's SOPs;
- Regionally monitored several clinical trial research sites via Pre-Site Selection Visits (PSSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), Remote Monitoring Visits (RMVs), Telephone Contact Reports (TCRs), and Close Out Visits (COVs);
- Completed detailed monitoring letters and visit reports within sponsor timelines;
- Created, analyzed, and followed up on weekly site-level reports for timely data entry, source data verification, query resolution, regulatory compliance, and action item resolution;
- Ensured proper storage, dispensation, and accountability of investigational products;
- Assessed completeness and accuracy of regulatory binders in addition to collecting/eFiling sponsor-requested study documents;
- Assisted in sponsor and federal audit responses;
- Interfaced MS Word, Excel, PowerPoint, Outlook, and Lync, to effectively manage and communicate study outcomes;
- Completed and submitted monthly RSM metric reports to Director of Global Monitoring Operations for review and approval;
- Ensured compliance with all sponsor-required training;
- Partnered with sites to ensure recruitment goals are met;
- Assisted sites with operational needs, such as vendor activities and site payments;
- Exceeded all departmental metrics and deliverables for the following activities: MVR submissions, freezing eCRFs, data cleaning, and expense reports;
- Attended and presented during regular regional teleconferences;
- Presented components of Global Monitoring Operations (GMO) Orientation to newly hired GMO personnel and served as assigned sponsor-assigned mentor to several new monitors;
- Operated as representative on Allergan projects managed by CROs;
- Reviewed and provided input to
protocols, paper Case Report Forms (CRFs), eCRFs and monitoring plans;
- Provided short- and long-term contract clinical trial monitoring services for CRO and sponsor projects;
- Conducted qualification, initiation, interim monitoring, remote monitoring, telephone contacts, and termination visits;
- Staffed clinical sites, CROs, and Sponsors with qualified research personnel to ensure proper study conduct and regulatory authority compliance;
- Trained entry-level clinical researchers in study monitoring, GCP, SOPs, regulatory binder composition, and protocol compliance for sponsor projects;
- Provided consulting services for clinical LLC
formations and Site Management Organizations;
- Monitoring and other study-related activities including GCP, SOP(s), and protocol compliance for sponsor projects;
- Conducted qualification, initiation, interim monitoring, and termination visits;
- Simultaneously and adequately managed more than 25 clinical trial sites; · Completed detailed monitoring letters and visit reports within CRO/sponsor timelines;
- Performed feasibility studies for potential clinical trials;
- Ensured proper storage, dispensation, and accountability of investigational drugs;
- Assessed accuracy and completeness of sites' regulatory binders in addition to collecting/eFiling study documents upon requested;
- Responded to sponsor and federal audits;
- Interfaced MS Word, Excel, PowerPoint, Outlook, Lync, to effectively manage and communicate study outcomes;
- Attended and presented during weekly WebEx conference calls to ensure study teams remained aware of project updates and deliverables;
- Trained new team members on protocol, regulatory binder composition, monitoring tasks, EDC, and CTMS during on-site co-monitoring visits;
- Ensured compliance with all sponsor- and CRO-required training;
- Met and exceeded
all monitoring and non-monitoring business metrics set forth by CRO and
sponsor;
- Monitoring and other study related activities including assurance of adherence to GCPs, SOPs, and study protocols;
- Monitored university affiliated clinical trials at on and off site locations; · Performed site selection visits, qualification visits, site initiation visits, interim monitoring visits, and close out visits;
- Performed feasibility studies for potential clinical trials;
- Ensured proper storage, documentation of use, and dispensation of investigational drugs;
- Responded to institutional and federal audits;
- Designed and managed projects for new team members, interns, and graduate students;
- Used MS Excel, PowerPoint, and other computational software to create spreadsheets, graphs, presentations, and statistically analyze data to effectively communicate study outcomes;
- Gave weekly PowerPoint and improvised chalk-talk presentations on project progress to team members;
- Fostered
intra- and inter-institutional collaborations between PIs;
- Monitored clinical trials to ensure subject safety and compliance with the study protocol, FDA regulations, and ICH/GCP Guidelines;
- Coordinated necessary activities required to set-up, monitor, and close-out clinical trial sites;
- Worked
closely with university and external sites' clinical research coordinators to
review and respond to data management inquiries;
Good Clinical Practices Code of Business Conduct and Ethics ICH Guidelines Drug Accountability Protocol Deviations Management and Reporting Corrective Action Preventative Action (CAPA) Protection of Confidential Business Information Personal Identifying Information (PII) HIPPA Guidelines Project Team Member Handover FDA Code of Federal Regulations DEA Guidelines Federal and Private Grant Writing/Review/Submission IACUC Guidelines
· McNair Scholar · University of California–Davis/Santa Barbara · NASA Scholar Summer Institute in Cognitive Neuroscience · Morehouse College Academic Scholarship Fellowship · North Houston Frontier's Club Scholarship · UTMB Frances Adoue Lynch Addiction · U.S. Department of Energy Scholarship Research Endowment Award · NSBE Scholarship · Morehouse College Department of Biology · U.S. Department of Energy Outstanding Scholar Award Seminar Series, Invited Alumni Speaker · Morehouse College Honor Roll and Dean's List · NASA Johnson Space Center - Intern · Morehouse College Department of Mathematics Awards Technical Writing Competition, 1st · Ruth L. Kirschstein National Research Services Award (NRSA) Place WinnerF31 Individual Pre-Doctoral Grant, Awardee – NIH National Institute for Drug Abuse (declined)
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