i have over 15 years of experience in Clinical trials, from being a site research Pharmacist handling imp and all that concerns import, storage, dispensing, accountability to its eventual destruction or return to the sponsor.
i have experience working in the following countries; kenya, tanzania, uganda, rwanda, malawi, zambia, south africa, mozambique, democratic republic of congo, nigeria, senegal, zambia, ivory coast, ehtiopia and gabon.
Senior Clinical Research Associate (SCRA) Nairobi, KenyaFebruary 2010 --- September 2014
all duties of a CRA and scra
Clinical Research Associate (CRA) Nairobi, KenyaOctober 2007 --- January 2010
all duties of a CRA
Clinical Research Associate (CRA) Nairobi, KenyaJune 2006 --- September 2007
handles all duties of CRA.
from site identification, selection, initiation, monitoring, audit and close out.
Chief Pharmacist Kisumu, KenyaFebruary 2002 --- February 2006
OrganizationPerspectiveAttention to detailCollaborationDependabilityResult OrientedKindness
Phase I R&D21 CFR Part 11Actions and modes of action of drugs in the human speciesActions and modes of action of human physiologyAdverse Events (AE)Business DevelopmentBusiness IntelligenceBusiness Process ImprovementClinical monitoringClinical operationsClinical researchClinical SuppliesClinical trial audits and inspectionsCRFCRF designCROCTMSCurrent Good Manufacturing Practice (CGMP)Customer ServiceData cleaningData entryData ManagementDrug Supply Management activitieseCRFEDCElectrocardiogram (ECG)EnglishGood Clinical Practice (GCP)Good Laboratory Practice (GLP)Good Manufacturing Practice (GMP)HospitalsInfectious diseasesInformed Consent DocumentsInformed Consent ProcessMultilingualNew Drug Application (NDA)Patient Follow UpPatient recruitmentPatient Screening and RecruitmentPharmaceutical IndustryPharmaceutical ManufacturingPharmaceutical ResearchPharmaceuticalsPharmaceuticsPharmacistsPharmacyPhase IPhase IIIPhase IIPhase IVPhases of clinical development (phase I to IV)Quality Assurance (QA)Quality Control (QC)Quality AuditingQuality ManagementQuality Management System (QMS)Regulatory ComplianceRegulatory RequirementsSerious Adverse Event (SAE)TranslationVaccines
Skills and Expertise
Create SOPs Build and manage the Trial Master File (TMF) Guide studentsAct as the main line of communication between the sponsor and the investigatorAdminister supply requestAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAdverse event reportingApprove consent documentsApprove drug supply Approve Label Master SheetApprove monitoring reportsApprove patient informationApprove queriesApprove suitability of patient information and consent documentsArchive documentationArchive study documentsArchive trial documentation and correspondence.Assist with site trainingAttend investigator meetingAttend at steering committee meetingsAttend seminarsCommunicate with investigatorCommunicate with sponsorCommunicationCompile informationComplete case report form (CRF)Complete study proceduresConduct close-out visitsConduct site initiationConduct studiesConduct research at universitiesConduct the trialConfirm protocol complianceCoordinate ethics committeeCoordinate projectsEnsure good clinical practice (GCP)Follow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesGuide studentsIdentify investigatorsIdentify and provide training to trial team and associated staffImplement Quality Management System (QMS)Informed consent processInitiate clinical trials Interact with CROsInteract with KOLInteract with nursesInteract with pharmacistsInteract with physiciansInteract with regulatory stakeholdersInventory ManagementLead teamsLiaise with research teamLiaise with doctors and other professionals throughout the studyManage Clinical Trial Management System (CTMS) Manage clinical suppliesManage regulatory activitiesManage subject consent formmanaging a small teamMonitor dataMonitoring enrolmentMonitoring subject compliancePatient recruitmentResolves queriesRetrieve study documentsReview clinical study reportsReview exclusion criteriaReview inclusion criteriaReview informed consent processReview monitoring reportsReview study protocolsSite managementSolve problemsStudy execution planSupervise clinical monitorsSupervise trial suppliesTrain on site staffWork cross-functionally
Post Graduate Certificate in Clinical Research Administration from Liverpool University in 2014
Degree in Pharmacy from Karnatak University in 1998
Training and Certification
CCRA in 2009 Certification
Registered Pharmacist (Dr.) in 2001 Certification