Aliki Martin
Bahama,NC
Summary
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.
Overview
16
16
years of professional experience
Work History
Safety Services Project Leader / Drug Safety - Pharmacovigilance Operations / Project Management
PAREXEL INTERNATIONAL
DURHAM, NC
11.2015 - 05.2023
- 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.
Senior Clinical Trials Quality Assurance (CTQA) Compliance Auditor
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.
Timeline
Interim Consultant / Subject Matter Expert
ADVARRA RESEARCH INSTITUTE
05.2023
Safety Services Project Leader / Drug Safety - Pharmacovigilance Operations / Project Management
PAREXEL INTERNATIONAL
11.2015 - 05.2023
Director of Clinical Research
DUKE CANCER NETWORK
11.2014 - 11.2015
Senior Clinical Trials Quality Assurance (CTQA) Compliance Auditor
DUKE UNIVERSITY SCHOOL OF MEDICINE ETHICS AND COMPLIANCE OFFICE
11.2007 - 11.2014
Member of the Duke (IRB)
DUKE UNIVERSITY INSTITUTIONAL REVIEW BOARD (IRB)
11.2007 - 11.2014
Doctor of Nursing Practice -
Duke University School of Nursing
Master of Science / Nursing Administration -
University of Phoenix
Bachelor of Arts, Education -
Caldwell College
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