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I have over 18 years of experience in Clinical Research, in early phase research, namely in Phase I and IIa, but also Phase III trials. I collaborated in the clinical development programs of six new chemical entities. Approximately 60 Phase I clinical trials were conducted under my coordination. During this time I had roles as Country Study Manager, Research Nurse Coordinator, Project Manager / Clinical Research Associate and Clinical Research Coordinator. Besides clinical research I also worked at a General Hospital as Registered Nurse during 19 years at Emergency Service and Oncology.

I have extensive work experience in clinical environments, and excellent communication and interpersonal skills. Clinical Nursing experience provided a strong medical foundation and Knowledge of a variety therapeutic areas. The clinical research and hospital experience gave me varied skills and the ability to work with many different types of people in a multidisciplinary team environment. Comfortable speaking with Research Nurses, Physicians, Study Coordinators, Principal Investigators and Clinical Directors. I am a responsible person, organized, hardworking, appreciate new challenges, self-motivated, always willing to learn from others and quick to develop new skills.

Please see my CV for additional information on my experience. I believe I could fit in the candidate profile you looking for. I will be available for additional information and possible interview.

Thank you for your time and consideration.

Sincerely,

Patrícia Graziela.

Experiences

Current Experience

  • Contry Study Manager

    Portugal
    Since July 2017

  • Research Nurse and Nurse Coordinator – Phase I Unit

    Portugal
    Since May 2013

Past Experience

  • Project Manager / Clinical Research Associate Portugal

    October 2015 --- September 2016

  • Clinical Research Coordinator Portugal

    January 2015 --- September 2016

  • Research Nurse Coordinator – Phase I Unit Portugal

    October 1999 --- January 2011

Personality

Self Assessment :
AdaptabilityAttention to detailCharmCollaborationCommunicativeCoordinationEfficiencyFlexibilityIndependenceIndividualityInterest in knowledgeKindnessOptimismOrganizationOrientationProblem solvingResponsibilityResult OrientedSelf-confidenceSelf-disciplineWillingness to compromise

Knowledge

Self Assessment :
Phase I R&D21 CFR Part 11Adverse Events (AE)Clinical DevelopmentClinical monitoringClinical operationsClinical researchClinical SuppliesClinical trial managementCoachingCRFData entryeCRFEmergency medicineEnglishGood Clinical Practice (GCP)HealthcareHospitalsICH guidelinesInformed Consent ProcessInformed Consent DocumentsLeadershipMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordOperations ManagementOutlookPatient recruitmentPatient Screening and RecruitmentPhase IPhase IIPhase IIIProblem SolvingProject CoordinationProject ManagementSafety reportingSerious Adverse Event (SAE)Team LeadershipWriting Study Procedures and SOPs

Skills and Expertise

Self Assessment :
Interact with nurses Interact with physicians Monitor a clinical studyAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAssess subject safetyAttend investigator meetingClinical data collectionCoach and provide guidance to clinical staff.Coach clinical staffCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamCommunicate with investigatorComplete case report form (CRF)Complete study proceduresConduct site initiationConduct studiesConduct the trialConduct supply issue resolution activitiescoordinating research projectsCoordinationCreate SOPsCreate study documentsCreates a collaborative team environmentData entryData verificationDetermine availability of facilities and equipment at the siteDetermine needsEnsure data consistencyEnsure data integrityEnsure good clinical practice (GCP)Identify and provide training to trial team and associated staffIdentify risksInformed consent processInitiate clinical trials Interact with nursesInteract with pharmacistsInteract with physiciansLead teamsLiaise with doctors and other professionals throughout the studyLiaise with research teamManage clinical suppliesManage contractors Manage subject safetyManage projects resourcesManage research projectsOrganise meetingsPatient recruitmentPeople managementPlan work to meet objectives and deadlinesproject managementProvide trainingReport serious adverse events (SAE)Resolves queriesReview informed consent processReview monitoring reports Create SOPsRespond to audit findingsSelect contractors Select investigatorsSet up a clinical studySite managementSolve problemsSupervise trial suppliesWork collaboratively with the other members of the clinical research team Verify dataTrain Staff

Education

  • Master in Pharmaceutical Medicine from Universidade de Aveiro in 2015
  • Post Graduate in Humanitarian Intervention from Universidade Fernando Pessoa in 2004
  • Bachelor in Nursing from Escola Superior de Enfermagem da Imaculada Conceição in 1995

Training and Certification

  • Msc in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Portuguese
Native
English
Professional Proficiency
Spanish
Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Research Associate (CRA) Clinical Trial Manager (CTM) Clinical Research Coordinator Clinical Project Manager (CPM) Clinical Research Manager
  • Locations I am interested in:
    Portugal
  • Work From Home:
    Yes, 0 to 5 days per week
  • International:
    No

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Portugal

Others

Driving License
  • Yes

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