Clinical Research Monitoring, Drug Safety Reporting, Clinical Trials
Resume:
DURRANT K BARASA, MBChB, MSc
*********@*****.***
EDUCATION
MS in Biotechnology, Regulatory Affairs concentration Johns Hopkins University
Training Certificate in Quantitative Methods in Public Health, (Oct 2009 – Dec 2011) Johns Hopkins School of Public Health
Bachelor of Medicine and Bachelor of Surgery (MBChB) University of Nairobi, Kenya
EXPERIENCE
Oct 2015 – Apr 2017 Medimmune (Aerotek Contractor) Data Management-Pharmacovigilance Liaison Specialist Liaison between the Departments of Patient Safety, Data Management, Clinical Operations, Clinical Programming, and the Safety Data Entry Site during the period of transition of responsibilities from Patient Safety to the latter four.
• Performed Serious Adverse Event (SAE) Reconciliation.
• Transferred knowledge of SAE Processing and Reconciliation to Data Management and Clinical Departments.
Aug 2014 – Oct 2015 Medimmune (Aerotek Contractor) Pharmacovigilance Support Specialist
• Prepared study specific reporting forms and completed other required study set-up forms
• Participated in clinical trial team meetings for assigned trials/programs
• Reviewed protocols to ensure standard safety language is included and identified any study specific safety reporting requirements
• Participated where appropriate in CRA/monitor and Investigator training including creation of slides and training materials
• Assisted in creating Safety Data Management Plans
• Performed reconciliation activities between clinical database and safety database
• Identified and prepared SAE case queries for assigned clinical trials in collaboration with Global Safety Physician
• Participated in therapeutic area case management meetings for assigned clinical programs
• Provided back-up support to the case handling group undertaking safety report intake, processing and reporting activities when required on an ad hoc basis
• Provided additional support to Senior or Lead PV Support Specialist for other development programs
DURRANT K BARASA, MBChB, MSc
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Oct 2013 – Aug 2014 Harris IT Services Corporation Clinical Research Associate II (Contractor
NIH/NCI)
• On-site clinical trial monitoring of Phase I/II cancer clinical trials. Assuring subject safety and study conduct in compliance with the protocols, ICH GCP, FDA regulations and institutional SOPs; and assuring data quality and integrity through on-site source verification and in-house review of eCRF data.
Jun 2011 – Sep 2013 Technical Resources International, Inc. Drug Safety and Pharmacovigilance Specialist I
• Responsible for collecting, evaluating and processing SAE reports received from the clinical sites including preparation of Safety Reports as per project and regulatory guidelines.
• Reviewed annual reports and CTA safety requirements as needed.
• Provided medical evaluation of adverse event reports as necessary
• Reviewed experimental protocols, risk lists and informed consent documents regarding safety information.
• Assisted in preparation of contract required reports, and developed/participated in updating new work instructions (PWIs, PSPs, SOPs) as necessary.
• Responsible for SAE Reconciliation processes in collaboration with various data coordinating centers.
2006 – 2011 Johns Hopkins University
Sr. Research Program Coordinator
• Responsible for coordinating Clinical Research study activities for the Pulmonary Hypertension Program including: Consenting and enrolling subjects, responsible for coordinating their visits, collection of data, records maintenance, managing regulatory and internal documentation, preparing and submitting event reports, collaborating with sponsors.
Medical Officer
Prior experience managing patients as a Clinician in Botswana and Kenya PROFESSIONAL DEVELOPMENT
Certified Clinical Research Professional (CCRP) Certification Society of Clinical Research Associates (SoCRA)
Principles and Practice of Clinical Research
The NIH Clinical Center (Oct 2013 – Mar 2014)
Clinical Research Professional Development Program (Jun – Aug 2010) Kriger Research Center, Toronto, Ontario
COMPUTER SKILLS
Competency in Microsoft Office (Word, Excel, Access, PowerPoint, Outlook). Working familiarity with Stata statistical package.
DURRANT K BARASA, MBChB, MSc
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LANGUAGES
English Advanced professional proficiency
Swahili Functional native proficiency
PROFESSIONAL ASSOCIATIONS OF INTEREST
Society of Clinical Research Associates
(SoCRA)
Drug Information Association (DIA)
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