Georgette Cox
Rockville
Summary
Dynamic Senior Manager in Clinical Development, adept at leading Phase II-IV trials and enhancing operational efficiency. Skilled in data analysis and fostering team collaboration, I excel in driving project success and ensuring compliance with GCP standards. Passionate about advancing clinical research and improving patient outcomes through innovative methodologies.
Overview
9
9
years of professional experience
Work History
SENIOR MANAGER, Clinical Development
Supernus Pharmaceuticals, Inc
Rockville
07.2022 - Current
- Program Involvement: Qelbree, Viloxazine ER.
- Indication: Attention Deficit/Hyperactivity Disorder.
- Clinical Trials: Phases II, III, and IV.
- Study Involvement: NCT04016779, NCT04143217, NCT02736656, NCT04786990, and NCT04781140.
- Executed tasks specific to various programs and therapeutic areas as needed.
- Executed CNS-focused biomedical trials employing interventional techniques such as randomized, double-blind placebo-controlled methodologies and OLE designs.
- Conducts comprehensive evaluations of Phase II-IV clinical trial documentation.
- Coordinated protocol-related regulatory submissions for agencies including FDA and IRB.
- Generated accurate and finalized documentation for Clinical Study Reports (CSRs), Investigator Brochures (IBs), and Safety Reports (e.g., 120-day, etc.).
- Verified consistency of TLFs with biomedical protocols for Phase III-IV trials.
- Utilized scientific expertise to influence operational decisions in clinical trial phases.
- Maintain compliance with protocols, ethical guidelines and good clinical practices.
- Identified areas needing improvement in business operations.
- Facilitated discussions on new and ongoing priorities during team sessions.
- Forged and nurtured strategic connections with key stakeholders to advance business goals.
- Instituted quality control protocols to maintain company benchmarks.
- Guided teams across various functions to accomplish project goals, promoting cooperation and effectiveness.
- Conducted literature reviews and synthesized research to identify gaps in knowledge and inform project objectives.
- Assisted in preparing presentations on findings from various studies conducted by the organization.
- Assessed the scientific content of team members' papers and delivered constructive critiques.
- Shared significant safety and efficacy data from Phase III and IV clinical trials at national conferences.
- Engaged in peer review for academic journals and conference submissions.
Lead Clin. Research Specialist, Anesthesiology
University of Maryland School of Medicine
Baltimore
04.2019 - 08.2020
- Handled daily logistics for a $3.5 million budgeted study on traumatic brain injury patients in critical care.
- Authored and revised continuing review reports, biomedical protocol amendments, consent forms, and study tracking documents.
- Conducted optimization assays for bioenergetic analysis of whole blood specimens.
- Tracked patient enrollment metrics using RMS queries and study logs.
- Drafted and refined SOPs for participant screening, enrollment, and retention in UM Shock Trauma and Research (STAR) clinical research projects.
- Authored and updated SOPs for anesthesiology lab personnel on specimen transport logistics, processing, and disposal.
- Ensured compliance by reporting adverse incidents and protocol deviations for biomedical clinical trials to institutional and US Air Force IRB.
- Delivered ICU nursing in-service research protocol training across three intensive care units: Trauma Resuscitation Unit, Neurotrauma ICU, Multi-trauma ICU.
- Oversaw preparation and filing of all regulatory research documents for military and university IRB submissions.
- Designed clinical research database to manage biological samples and chart variables electronically through EPIC with the use of REDCap.
- Established standardized procedures tailored to distinct research domains.
- Obtained data from patient medical records, histories and surveys.
- Entered test data into analysis programs and databases to assess results.
CLINICAL RESEARCH PROJECT MANAGER
Arundel Medical Center
Annapolis
09.2018 - 12.2018
- Created electronic database system to centralize clinical trial data points for enhanced quality oversight.
- Resolved internal and sponsor-related queries through electronic data capture systems.
- Managed case report forms (CRFs) in compliance with IRB-approved protocols.
- Monitored enrollment status of study participants throughout recruitment and retention phases.
- Tracked patient enrollment metrics using study logs.
- Conducted patient screenings for medical eligibility based on study criteria using EMR.
- Oversaw reporting of adverse and serious events as well as protocol deviations for biomedical clinical trial protocols to regulatory authorities and sponsors.
- Coordinated data preparation for site monitoring and close out visits.
- Managed clinical trials ensuring compliance with FDA, OHRP, GCP, and institutional protocols.
- Led and trained clinical research coordinators, fellows, and assistants.
- Discovered new clinical research opportunities for departmental growth.
- Facilitated study visits and protocol-mandated interventions with cross-functional services.
- Streamlined preparation and submission of study start-up and close-out documents based on timelines, medical site input, and requirements.
- Communicated with research administration to manage clinical research budget.
- Coordinated payment disbursement and reimbursement processes for clinical trial participants.
- Supervised completion of final study requirements, including trial closure and audit preparation.
- Oversaw study team to achieve critical recruitment milestones and deliverables.
- Oversaw protocol adherence to reduce protocol deviations.
- Handled data collection and management.
- Oversaw logistical support for study completion, including trial closure, audit preparedness, and stakeholder communication.
- Performed internal reviews for source document sufficiency and CRF development.
- Managed day-to-day operations associated with ongoing clinical research projects.
- Conducted prescreening to determine eligibility of possible subjects.
CLINICAL RESEARCH PROJECT MANAGER
ACell, Inc
Columbia
05.2018 - 07.2018
- Assessed CRO and medical center budget proposals to offer biostatistical, DSMB, and clinical research support for sponsor-initiated 510K PMA submissions.
- Created and refined materials for clinical research including monitoring plans, data management strategies, and analysis procedures.
- Monitored sponsor-based timelines to guarantee study site and CRO deliverables achieved milestone targets within budgetary forecasts.
- Enhanced and modified internal SOPs, as well as clinical research documents, for preservation in electronic document sharing system.
- Assessed potential target sites to enhance efficiency of investigator-initiated studies.
- Reviewed CRO budget proposals for enhancing resources in biomedical clinical trials in response to RFPs.
- Planned and led sponsor-initiated multi-site clinical trials from Pilot studies to Phase IV.
- Functioned as primary clinical trial liaison among research leadership, medical sites, and in-house counsel for specific CTAs.
- Drafted and refined documentation for clinical trials, including protocols, consent forms, and report forms.
- Planned and coordinated site initiation visits.
- Collaborated with legal department to draft and review non-disclosure agreements for sites and vendors.
- Coordinated investigator meetings and organized site initiation visits.
- Monitored, organized, and addressed all issues related to medical device accountability and distribution for clinical research studies.
- Conducted site visits to uphold GCP standards and regulations.
DIVISIONAL RESEARCH PROJECT MANAGER
GASTROINTESTINAL, Emory University School of Medicine/The Emory Clinic
Atlanta
09.2016 - 01.2018
- Led clinical trial workflow and managed four biomedical trials including Phase II.
- Managed multiple international RCTs and Phase IV monitoring trials for surgery research subgroups.
- Ensured compliance with IATA standards for international shipments of biological samples.
- Facilitated coordination and distribution of investigational products for clinical trial participants via Investigational Drug Service.
- Reviewed clinical trial budgets and negotiated increased allocation for internal training meetings.
- Delivered comprehensive health education on investigational product usage, adverse event reporting, and symptom monitoring.
- Facilitated acquisition of medical devices for clinical trials via department purchasing teams.
- Streamlined investigational drug processes through effective coordination with IDS and implementation of IWRS system.
- Scheduled and coordinated sponsor monitoring visits for investigational product oversight across global and domestic clinical trials.
- Coordinated monitoring sessions for PI and sponsor.
- Directed clinical trial initiation through site suitability process, IRB protocol review, and submission of regulatory documents.
- Assisted in managing documentation for FDA Form 1572 and annual IND reports during Phase I of a pharmaceutical trial.
- Established robust professional collaborations with international sponsors, internal clinical departments, regulatory entities, patients' families and CROs.
- Developed and launched participant welcome packets for protocols and site-specific needs.
- Ensured precision in revisions for sponsor billing processes across clinical and research areas.
- Coordinated processing of non-purchase orders via hospital supply chain and receiving units.
- Oversaw case report form management and regulatory binder maintenance for accurate data collection.
- Entered comprehensive patient information across multiple EDC platforms.
- Addressed EDC queries for lockout and database completion.
- Resolved audit findings by implementing corrective action plans.
- Streamlined IRB submission process by revising DSMB protocols across core and external PI-led projects.
- Ensured timely submission of all IRB protocol amendments and revisions.
- Executed thorough medical chart evaluations for determining eligibility criteria.
- Negotiated contracts with Office of Clinical Research to enhance budget for protocol training activities.
- Trained over 50 surgery nurses and OR techs in sponsor protocols to enhance compliance.
- Developed meeting agendas and facilitated internal departmental discussions on sexual health research linked to parathyroidectomy.
- Coordinated cooperative efforts between endocrine researchers and health policy economists for cost-effectiveness analysis.
- Contributed to a chapter on managing neuropsychiatric symptoms in cases of parathyroidectomy for a surgery textbook (in draft).
- Managed and reported adverse events and serious AES to institutional review boards.
- Led database builds integrating retrospective and prospective data for paraesophageal hernia repair and parathyroidectomies.
- Built custom REDCap platform for efficient capture of validated research data.
- Collected biological specimens for biomarker analysis.
- Conducted and recorded patient EKGs for data collection.
- Completed internal IATA training for shipping biological specimens domestically and internationally.
- Managed distribution of IDPs within institution's IDS and pharmacy for clinical trials.
- Provided guidance to patients on usage instructions for investigational drugs.
- Coordinated protocol training for proper handling and disposal of IP.
- Ensured alignment of study management activities with cGMP, GCP, and ICH standards through close coordination with Office of Research Administration.
- Worked jointly with IDS to enhance synchronization in vendor management, distribution protocols, and system activities.
- Developed strategies to ensure successful completion of projects within budget constraints.
- Organized meetings between researchers, sponsors, and other relevant parties.
Education
PHD - SOCIAL AND BEHAVIORAL SCIENCES
Johns Hopkins University, Bloomberg School of Public Health
Baltimore, MD, USA12.2012
MSW - CLINICAL SOCIAL WORK
University of Pennsylvania, School of Social Policy And Practice
Philadelphia, PA, USA05.2008
BA - HEALTH AND SOCIETIES
University of Pennsylvania
Philadelphia, PA, USA08.2006
Skills
- Data Analysis
- Precision in Task Execution
- Scientific Study Support
- Analytical Problem Solving
- Research Methodology
- Biomedical protocol development
- Team collaborations
- Scientific teaching
- Manuscript writing
- Communication
- Quantitative data analysis
- Data Trend Evaluation
- Comprehensive Data Reporting
- STATA Data Analysis
- Quantitative Research with SPSS
- Clinical trial life-cycle management
- Human Subjects Recruitment
- Good Clinical Practice (GCP)
- Ethical/Patient Safety Oversight
- Clinical Trial Electronic Data Capture System (EDC)
- Electronic Medical Record (EMR) Database
- REDCap
- Athena
- EPIC
- Medidata Rave
- Literature/Systematic Reviews
- Interdisciplinary Collaboration
- Project Management Facilitation
- Microsoft Office
- Clinical trial management
- Protocol development
- Team leadership
- Stakeholder engagement
- Problem solving
- Partnership development
- Troubleshooting and problem resolution
- Cross-functional collaboration
- Analytical skills
References
- Joe Sharma, MD, Associate Professor and William C. McGarity Chair of Surgery, Emory University School of Medicine, 1525 Clifton Road, Atlanta, GA, 30322, (404) 778-3322, jsharm3@emory.edu
- Susan Safley, PhD, Assistant Professor (emeritus), Emory University School of Medicine, 1525 Clifton Road, Atlanta, GA, 30322, (404) 712-9676, ssafley@emory.edu
- Rajiv Rimal, PhD, MA, Chair, Department of Health, Behavior, and Society, The Johns Hopkins Bloomberg School of Public Health, 624 N. Broadway, Hampton House, Room #704, Baltimore, MD, 21205, rrimal@jhu.edu
- Kimberly Hayman, B.S., Clinical Operations Project Manager, 9715 Key West Ave., Rockville, MD, 20850, 240-403-5709, 443-255-7840, khayman@supernus.com
- Deborah Smith-Reynolds, PhD, Associate Director, Medical Writing, 9715 Key West Ave., Rockville, MD, 20850, 760-468-2070, dsmithreynolds@supernus.com
Publications
- Childress, A., Asubonteng, K., Cox, G., Earnest, J., Hayman, K., Yarullina, I., & Rubin, J. (2025). Viloxazine Extended-Release Administered With Psychostimulants in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Phase 4, Open-Label Trial. Journal of Child and Adolescent Psychopharmacology.
- Neuropsychiatric Symptoms in Primary Hyperparathyroidism: A Brief Review, Cox, G., Liu, J.L., in review, Current Issues in Primary Hyperparathyroidism, Nova Science, Hauppauge, New York
- The Effect of Coercion on Health: An Empirical Test of the Dutton and Goodman (2005) Model of Intimate Partner Violence, Cox, G., 2013, ProQuest Dissertations, 3536081
- A Systematic Review of Fathers' Involvement in Programs for the Prevention of Child Maltreatment, Smith, T.K., Bair-Merritt, Duggan, A., Cox, G., 2012, Child Abuse Review, 21, 237-254
Accomplishments
Pre-doctoral Fellowships/Scholarships:
- National Institute of Mental Health (NIMH) Interdisciplinary Training in Research in Violence Affecting Families (2T32MH020014NlMH, 2019)
- National Institute of Child Health and Development (T32-HD064428NlCHD) T-32 Predoctoral Fellow, 2008-09, 2010-11
- US Center for Disease Control and Prevention (CDC)/Kennedy Krieger Institute (KKI Research in Science Education (RISE) Predoctoral Extern, 2010-11
- Johns Hopkins Bloomberg SPH Department of Health and Behavior Scholarship, 2008-2012
- Johns Hopkins Women’s Club Scholarship, 2008
Undergraduate Research Honors
- University Scholars Undergraduate Research Honors distinction, University of Pennsylvania
Timeline
SENIOR MANAGER, Clinical Development
Supernus Pharmaceuticals, Inc
07.2022 - Current
Lead Clin. Research Specialist, Anesthesiology
University of Maryland School of Medicine
04.2019 - 08.2020
CLINICAL RESEARCH PROJECT MANAGER
Arundel Medical Center
09.2018 - 12.2018
CLINICAL RESEARCH PROJECT MANAGER
ACell, Inc
05.2018 - 07.2018
DIVISIONAL RESEARCH PROJECT MANAGER
GASTROINTESTINAL, Emory University School of Medicine/The Emory Clinic
09.2016 - 01.2018
PHD - SOCIAL AND BEHAVIORAL SCIENCES
Johns Hopkins University, Bloomberg School of Public Health
MSW - CLINICAL SOCIAL WORK
University of Pennsylvania, School of Social Policy And Practice
BA - HEALTH AND SOCIETIES
University of Pennsylvania
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