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Summary

  • Consultant Senior Clinical Research Associate and Project Manager
  • Provide internal Monitoring support as well as Feasibility, Regulatory Submissions, Quality Assessment, Laboratory & Pharmacy assessment support to the Clinic. Provide Project Management assistance to Principal Investigator (PI) and site Personnel Training. Provide ICH-GCP training to site staff. Ensure site Quality Management Plans are followed. Identification of potential site issues and development of Corrective Action/ Preventive Action (CAPAs) to assist clinical staff and ensure a timely resolution of those issues. Pro-actively prepare the Clinic for Audits and Regulatory inspections. Provide Oversight activities and assistance to the Principal Investigator (PI) and the Clinical Operation Team.

Experiences

Current Experience

  • Consultant Senior Clinical Research Associate and Project Manager Africa
    Since August 2014

    • Consultant Senior Clinical Research Associate and Project Manager

    Provide internal Monitoring support as well as Feasibility, Regulatory Submissions, Quality Assessment, Laboratory & Pharmacy assessment support to the Clinic. Provide Project Management assistance to Principal Investigator (PI) and site Personnel Training. Provide ICH-GCP training to site staff. Ensure site Quality Management Plans are followed. Identification of potential site issues and development of Corrective Action/ Preventive Action (CAPAs) to assist clinical staff and ensure a timely resolution of those issues. Pro-actively prepare the Clinic for Audits and Regulatory inspections. Provide Oversight activities and assistance to the Principal Investigator (PI) and the Clinical Operation Team.

Personality

Self Assessment :
Attention to detailCreative thinkingCommunicativeFlexibilitySelf-disciplineWillingness to compromiseProactivityStrategic thinking

Knowledge

Self Assessment :
Diabetes Cell biology Phase I21 CFR Part 11 Scientific writing NegotiationActions and modes of action of drugs in the human speciesAntibodiesAuditingBiopharmaceuticalsBiomedical SciencesBudgetingCardiovascular diseasesClinical monitoringClinical researchCTMSData cleaningEfficacy trialsELISAEndocrinologyEndocrinology and metabolismEmergency medicineEnglishFlow CytometryGood Clinical Practice (GCP)ImmunologyLife SciencesClinical study reportsGood Laboratory Practice (GLP)

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Create SOPs Guide students Interact with nurses Interact with physicians Monitor a clinical studyApprove monitoring reportsArchive trial documentation and correspondence.Attend steering committeeAttend seminars, courses and meetings within and outside the companyCollaborate with medical teamCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with project teamCommunicate with sponsorCommunicate with investigatorCommunicate effectively on different company levelsComplete case report form (CRF)Conduct monitor visitsConduct university research control different protocol versions and other essential documentsCoordinate projectsCoordinate ethics committeeCreate clinical project documents according to the protocol

Education

  • Master (MSc.) in Medical Virology in Biomedical Sciences from Medical University of the Southern Africa, South Africa in 2005

Training and Certification

  • Good Clinical Practice (GCP). in 2015 Certification
  • United Nations Department of Safety and Security - Basic Security in Field II in 2015 Certification
  • US Agency for International Development (USAID) Training on Monitoring & Evaluation (M&E) and Data Demand and Use Training in 2015 Certification
  • Laboratory Auditor in 2007 Certification
  • Clinical Research Associate in 2006 Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency
German
Elementary Proficiency

Work Preferences

  • Notice Period:
    2 weeks
  • Positions I am interested in:
    associate Clinical Project Manager Associate Scientist Clinical Project Leader Clinical Operations Manager Clinical Research Manager Clinical Research Associate (CRA) Clinical Project Manager (CPM)
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer
  • International:
    Yes

Area / Region

Cape Town, Western Cape, South Africa

Others

Driving License
  • No