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GCP Training Day 13/10/04An Introduction to ClinicalResearchPresented by: Sabrina RamkellawanMarch 30, 2016Getting Started in Clinical ResearchThis webinar is for anyone interested inlearning more about the clinical research fieldand how to enter and get started in ClinicalResearch.Essential Documentation1
GCP Training Day 13/10/04PresenterSabrina Ramkellawan is the Vice President of Operations atApollo Applied Research. In this capacity, she overseescollaborative research partnerships and the conduct of researchstudies with the goal to advance research in medical cannabis.Sabrina is also a Professor and the Program Coordinator of theClinical Research Program at Seneca College. Prior to joiningApollo Applied Research, she was the Director of Operations atINC Research overseeing the operations of the ContractResearch Organization in Toronto. In this capacity, she wasresponsible for the conduct of phase I clinical trials. In addition,Sabrina has Nursing experience in various areas includingCritical Care, Pediatrics and Mental Health.Learning ObjectivesUpon completion of this Webinar, attendees should be able to: Determine whether clinical research is a good fit for youDescribe the various roles and positions within the clinical research industryand how these roles fit within the drug development processDiscuss the required qualifications and competencies of clinical researchprofessionalsDiscuss the types of certifications available for various roles and positionswithin the clinical research industryDescribe what is it like to work in clinical research through “A day in the life”interviews with research professionals in the fieldUtilize interview tips to prepare and plan for upcoming interviewsUtilize networking and social media to make professional connections,improve your brand and get noticed.Essential Documentation2
GCP Training Day 13/10/04Are you a good fit for clinicalresearch?5Are you a good fit for clinical research?Take the short quizEssential Documentation3
GCP Training Day 13/10/04Are you a good fit for clinical research? Team workFlexible and adaptable to changing prioritiesLeadership & ProfessionalismKnowledgeable in regards to regulations, guidelines,Good Clinical Practice, Good DocumentationPractices Being detail-oriented is critical and can’t beunderstated.The different roles and positionsin clinical research8Essential Documentation4
GCP Training Day 13/10/04The different roles and positionsin clinical researchPrincipalClinicalResearch InvestigatorCoordinator CRA)Quality Assurance(QA)/Quality Control (QC)Project Manager (PM)Regulatory Affairs (RA)Medical Writer/DataManagement/InformaticsRoles &PositionsBiostatistics/Statistician/Research ScientistMedical &Laboratory StaffClinical TrialAdministrator(CTA)PharmacovigilanceOther Specialist/Roles e.g.Patient Recruitment Specialist,IRB Staff, Budgets & ContractsPositions related to the drug developmentprocessDrug DiscoveryThis process starts withan idea and a targetcompound is identifiedPosition(s):Research Scientist,InformaticsPreclinical TestingPreclinical Testing includesboth in vitro and in vivotestingPosition(s):Research Scientist;Medical Writer,InformaticsRegulatory ApprovalClinical Trials I-IIIClinical Trials are done toshow that the drug issafe and worksPosition(s):See next SlideEssential DocumentationApplication toRegulatory Body toapprove the drug tomarketPosition(s):Regulatory Affairs,Project ManagerRegulatory ApprovalApplication toRegulatory Body to testin HumansPosition(s):Regulatory Affairs,Project ManagerPost Market-ClinicalTrials Phase IV ClinicalTrials are done to showthat the drug continuesto be safePosition(s):See next Slide5
GCP Training Day atedEnrollmenttheClinicalTrial ProcessPreparationCollectionAnalysis FlowStudyDefinitionProtocolDesign &ApprovalsSiteSelection/SupplyManagementBudget &Contracts-PI-PM-RegulatoryAffairs-Medical EthicsProfessional/IRB-PI-PM-QA-CRA-CRC-Budget& ContractSpecialistEDC, IVR,PatientCTMS, l andLaboratoryStaffReportWriting QA-PMWhat is it like to work inclinical research?12Essential Documentation6
GCP Training Day 13/10/04What is it like to work in clinical research?“A day in the life”Elizabeth HollingdrakeGregory StaiosTypes of organizations that hireclinical research professionals14Essential Documentation7
GCP Training Day 13/10/04Types of organizations that hireclinical research agementOrganizationCompetencies, experience andcertifications16Essential Documentation8
GCP Training Day 13/10/04Competency domains for the clinical researchprofessionalExperience If you are looking to enroll in a clinical research program, look forschools that offer a work placement. This is a great way to gainsome experience Be flexible as you will likely need to apply for an entry-levelposition to get your foot in the door. It’s best not to “get set” on the specific company or type ofcompany Don’t be limited by geography. A great opportunity may requirethat you travel for an hour or even relocate Look for job shadow or internship opportunitiesEssential Documentation9
GCP Training Day 13/10/04CertificationsAssociationCertificationACRP (Association of Clinical ResearchProfessionals)CCRA (Certified Clinical Research Associate)CCRC (Certified Clinical Research Coordinator)CPI (Certified Principal Investigator)RAC (Regulatory Affairs Certificate)RAPS (Regulatory Affairs Professional Society)SOCRA (Society of Clinical Research Associates)CCRP (Certified Clinical Research ProfessionalCertificate)ASQ (American Society for Quality)CQA (Certified Quality Auditor)PMI (Project Management Institute)PMP (Project Management Professional)Society for Clinical Data ManagementCCDM (Certified Clinical Data Manager)Salaries20Essential Documentation10
GCP Training Day 13/10/04SalariesJob TitleSalary RangeSalary MedianClinical Research Coordinator 33,869 - 65,597 46,354Clinical Research Associate 41,218 - 84,477 60,880Principal InvestigatorClinical Research NurseProject ManagerResearch ScientistMedical WriterStatisticianData Manager 64,564 - 190,347 50,602 - 87,588 54,447 - 120,403 45,676 - 110,541 49,445 - 112,505 46,444 - 107,866 35,829 - 98,351 102,119 64,553 84,214 75,508 72,227 72,114 53,621Regulatory Affairs Manager 57,801 - 122,733 87,738Reference: Payscale.com (funds are in US Dollars)Networking and Social Media22Essential Documentation11
GCP Training Day 13/10/04Networking and social media Two types of networking: in-person and online soutilize both options Your network is larger than you think! Reach out to your network Focus on building relationshipsUsing social media LinkedInTwitterFacebookGoogle (Plus)Essential Documentation12
GCP Training Day 13/10/04References-A New Approach to developing the CRA workforce-2015 Career and Salary Benchmark Reports-Moving from Compliance to CompetencyA Harmonized Core Competency Framework for theClinical Research Professional25Essential Documentation13
Apollo Applied Research, she was the Director of Operations at INC Research overseeing the operations of the Contract Research Organization in Toronto. In this capacity, she was responsible for the conduct of phase I clinical trials. In addition, Sabrina has Nursing experience in various areas including Critical Care, Pediatrics and Mental Health.
