With extensive experience in pharmacovigilance operations, clinical research, and medical writing both in academia and at a CRO, I am a highly skilled professional delivering exceptional services that exceed industry standards.
Managed all Medical Services and Pharmacovigilance (PV) projects - medical monitoring, clinical endpoint, data monitoring, data analysis, and post-marketing
Direct and cross-functional management in a matrix environment with colleagues across R&D.
Director of Clinical Research
DUKE CANCER NETWORK
DURHAM, NC
11.2014 - 11.2015
Managed the development and ongoing operations of clinical research programs at 18 affiliate sites
Participated in the assessment of affiliate sites’ capabilities to implement clinical research and regularly reviewed clinical trials to determine appropriateness for member institutions.
DUKE UNIVERSITY SCHOOL OF MEDICINE ETHICS AND COMPLIANCE OFFICE
DURHAM, NC
11.2007 - 11.2014
Supported the Duke University School of Medicine Ethics and Compliance Officer in the continuous development and enhancement of the overall risk management and risk mitigation strategies and promoted best practices.
Member of the Duke (IRB)
DUKE UNIVERSITY INSTITUTIONAL REVIEW BOARD (IRB)
DURHAM, NC
11.2007 - 11.2014
Voluntarily served on the IRB as a voting member and primary reviewer
Preliminary review of two study-related documents (i.e
Protocol, amendment, and informed consent) per month for approval or continued renewal.
Interim Consultant / Subject Matter Expert
ADVARRA RESEARCH INSTITUTE
COLUMBIA, MD
05.2023
Provides expertise in clinical, quality, auditing, medical writing, and other regulatory specialty areas as needed in the R&D industry.
Education
Doctor of Nursing Practice -
Duke University School of Nursing
Master of Science / Nursing Administration -
University of Phoenix
Bachelor of Arts, Education -
Caldwell College
Skills
Strategic Plan Development
Standard Operating Procedures (SOPs)
Budget & Financial Management
Resource Management
Regulatory Compliance
EudraCT Registration
Regulatory Inspections (ie FDA, MHRA) Compliance Site Audits – Routine and For Cause
HIPAA and 21 CFR Part 11 Compliance
Clinical Project Management
Conflict Management
Flexibility
Accuracy
Mentorship
Excellent oral and written communication presentation skills
Provides Leadership and provides feedback for cross-functional teams
Accountability
Attention to Detail
Solving complex problems
Team Building
Fostering innovation
Technical Expertise (including presentation) and written communication
Project management skills
Regulatory Reporting to US & International Sites (FDA, EMA, MRHA, PMDA, Health Canada)
FDA Investigational New Drug (IND) submission
New Drug Applications (NDA) submission
Investigational Device Exemption (IDE) submission
Expanded Use Drugs / Devices
Biologics
External & Internal Client and Vendor Negotiations / Vendor Oversight
Experience in Various Therapeutic Areas, Clinical Development for Phases I-IV
Signal Detection
Experience with Scientific Writing / Medical Narratives, ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
Writer / reviewer for 15 years for principal investigator-initiated clinical studies (protocol, consent form, IND, NDA, IDE) and completion of a broad range of documents and reports Adherence to client style guide templates
Contributes to Clinical Study Report (CSR)
MS Office - Power point, WORD, Adobe Acrobat, Excel; Google Docs, Share point
Pharmacovigilance, Processing - case management (Argus) and Reporting - Individual Case Study Reports (ICSR), Aggregate Reports, MedDRA, WHO Drug Dictionary
Subject Matter Expert (SME) in clinical, quality auditing for GCP & GVP, medical writing, IRB submissions, protocols, ICF
Vendors / Systems – Safety Database (Argus Safety); Clinical Databases (Medidata Rave, Rave X, Data labs)
Quality Management System - QMS (QuIPS, Trackwise)
TMF (Veeva Vault)
Budget (Precision, PRISM, RAFT, O2C, Planisware)
Safety Reporting (Safety Information System)
Country Reporting and Regulatory Guidance Database (Direct, ISRR)
Personnel (Impact Harmony)
Translation (TransPerfect)
24/7 Medical Emergency Contact (Calyx Contact Center)
Quality Assurance Controls
Process Improvement
Expense Control
Continuous Improvements
Incidents Management
Contract Oversight
Financial Acumen
Operations Management
Staff Management
Processes and Procedures
Negotiation
Process Monitoring and Improvement
Therapeutic Areas Of Expertise
Pediatric / Adult Oncology / Hematology
Vaccine development
Immunology
Genitourinary
Gastroenterology / Hepatology
Anesthesiology / Regional Blocks
Cardiology
Infectious Diseases / HIV / Covid-19
Neurology / Neurodegenerative Diseases
Orthopedics
Pulmonology
Certifications Affiliations Licenses
Advanced International Pharmacovigilance and Argus Safety Certification (APVASC)
Stanford University, Medical Writing Certificate
American Medical Writers Association (AMWA)
American Nurses Association
North Carolina Nurses Association, Triangle Region
North Carolina Registered Nurse, Nursing License # 77306
SOCRA Certified Clinical Research Professional, CCRP 2005-2015
Awards
Article selected as featured article for Duke Nursing Publication
Opinion Editorial selected to be published in a local newspaper by Duke editorial staff
Recipient of North Carolina Nurses Association, Triangle Region, Research Award / Poster Presentation, Screening All Eligible Patients for Clinical Trials. Poster 2013
Member of Sigma Theta Tau, Beta Epsilon Chapter, Nursing Honor Society, Duke University School of Nursing
Publications
Aliki Martin, RN, MSN, CCRP, DNP Student; John Falletta, MD, Chairman, Duke Institutional Review Board, Professor, Pediatrics-Hematology/Oncology; Kevin P. Weinfurt, PhD, Professor, Medical Psychology, Duke Clinical Research Institute; Jody Power, MS, MBA, Exec Director, Duke Institutional Review Board; Ricardo Pietrobon, MD, PhD, MBA, Associate Professor, Surgical Sciences, Duke University Medical Center; Isaac Lipkus-Reiner, PhD, Professor, Duke University School of Nursing, Durham, North Carolina 27710 USA. Screening All Eligible Patients for Clinical Trials. Poster 2013.
Martin, A. H. Opinion Editorial-Why are we discharging our patients to the street? Herald Sun. March 23, 2012.
Klein SM, Steele SM, Nielsen KC, Pietrobon R., Warner DS, Martin A, Greengrass RA. The difficulties of ambulatory interscalene and intra-articular infusions for rotator cuff surgery: a preliminary report: [Difficultes des perfusions interscalenes et intra-articulaires ambulatoires pour la reparation de la coiffe des rotateurs: un rapport preliminaire]. Canadian Journal of Anaesthesia. 50(3):265-9, 2003 March.
Juan Alonso-Echanove, MD; Jonathan R. Edwards, MS; Michael J. Richards, MB, BS; Patrick Brennan, MD; Richard A. Venezia, PhD; Janet Keen, RN, MSN; Vivian Ashline, RN; Kathy Kirkland, MD; Ellen Chou, RN, BSN; Mark Hupert, MD; Abigail V. Veeder, BS; Janice Speas, RN, MSN; Judy Kaye, RN, PhD; Kailash Sharma, MD; Aliki Martin, RN, BA; V. Dianne Moroz, RN, MS; Robert P. Gaynes, MD. Effect of nurse staffing and antimicrobial-impregnated central venous catheters on the risk for bloodstream infections in intensive care units. The University of Chicago Press on behalf of The Society for Healthcare Epidemiology of America. Vol. 24 No. 12 December 2003.
Klein SM, Nielsen KC, Greengrass RA, Warner DS, Martin A, Steele SM. Ambulatory discharge after long-acting peripheral nerve blockade: 2382 blocks with ropivacaine. Anesth Analg 2002 94: 65-70.
Buckenmaier CC 3rd, Nielsen KC, Pietrobon R, Klein SM. Martin AH, Greengrass RA, Steele SM. Small-dose intrathecal lidocaine versus ropivacaine for anorectal surgery in an ambulatory setting. Anesthesia & Analgesia. 95(5):1253-7, 2002 November.
Klein SM, Nielsen KC, Martin A, White W, Warner DS, Steele SM, Speer KP, Greengrass RA Interscalene brachial plexus block with continuous intraarticular infusion of ropivacaine. Anesth Analg 2001; 93:601-5.
<ul><li>- Working in Collaboration with the Central Quality team in the development of Quantitative checklists for Aggregate reports.</li><li>- Performing QR of Safety reports i.e, PADER, DSUR, PBRER and DSURs.</li><li>- Managing QR Team for Safety reports and acting as a training lead for Safety Writing Team.</li><li>- Prepared and Performed QC of the trackers for RSI project.</li><li>- Performed Quality review of cases in Argus database for VOQR project. Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Participating in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Responsible for reviewing the SOPs, job aids as per program specific requirements.</li><li>- Acting as a subject matter expert and helping the team members with day-to-day trouble shooting activities.</li><li>- Signal detection and risk management plan authoring or other assigned PV related activities for client's product(s), per the regulations and SOPs when required.</li><li>- Exhibiting a growing awareness of program strategy and thinking capability alongside independence.</li><li>- Reviewing and providing solutions for issues relating to program delivery or escalating appropriately to the Team Lead / Program Lead as required.</li><li>- Providing standards for gathering information for use in trend analysis.</li><li>- Involved in people development in partnership with PDG leads.</li><li>- Ensuring that all training (internal training and client training) are successfully completed in a timely manner.</li></ul> at Syneos Health<ul><li>- Working in Collaboration with the Central Quality team in the development of Quantitative checklists for Aggregate reports.</li><li>- Performing QR of Safety reports i.e, PADER, DSUR, PBRER and DSURs.</li><li>- Managing QR Team for Safety reports and acting as a training lead for Safety Writing Team.</li><li>- Prepared and Performed QC of the trackers for RSI project.</li><li>- Performed Quality review of cases in Argus database for VOQR project. Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Participating in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Responsible for reviewing the SOPs, job aids as per program specific requirements.</li><li>- Acting as a subject matter expert and helping the team members with day-to-day trouble shooting activities.</li><li>- Signal detection and risk management plan authoring or other assigned PV related activities for client's product(s), per the regulations and SOPs when required.</li><li>- Exhibiting a growing awareness of program strategy and thinking capability alongside independence.</li><li>- Reviewing and providing solutions for issues relating to program delivery or escalating appropriately to the Team Lead / Program Lead as required.</li><li>- Providing standards for gathering information for use in trend analysis.</li><li>- Involved in people development in partnership with PDG leads.</li><li>- Ensuring that all training (internal training and client training) are successfully completed in a timely manner.</li></ul> at Syneos Health
<ul>
<li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li>
<li>Department of Agriculture (USDA) and the U.S</li>
<li>Department of Homeland Security (DHS)</li>
<li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li>
<li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li>
<li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li>
<li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li>
<li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li>
<li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li>
<li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li>
<li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li>
<li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li>
<li>Implemented quality control measures throughout each stage of a project's lifecycle.</li>
<li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li>
<li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li>
<li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li>
<li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li>
<li>Trained junior staff on best practices for managing multiple projects simultaneously.</li>
</ul> at Defense Contracting Activity, LLC<ul>
<li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li>
<li>Department of Agriculture (USDA) and the U.S</li>
<li>Department of Homeland Security (DHS)</li>
<li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li>
<li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li>
<li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li>
<li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li>
<li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li>
<li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li>
<li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li>
<li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li>
<li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li>
<li>Implemented quality control measures throughout each stage of a project's lifecycle.</li>
<li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li>
<li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li>
<li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li>
<li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li>
<li>Trained junior staff on best practices for managing multiple projects simultaneously.</li>
</ul> at Defense Contracting Activity, LLC