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Qu'est-ce que Determine ?

Determine est un éditeur qui propose des solutions de gestion des processus et des problématique métiers : finance, achat, comptabilité, légal, contrôle de gestion et traitement des factures.

Exemple de missions d'Ehouman, freelance Determine habitant l'Ain (01)

PROFESSIONAL EXPERIENCE:

Research study:
• Research Protocol writing and implementation
• Writing of research papers and presentation at international conferences

Clinical Research Site selection and set up:
• Identification of Principal Investigators
• Site selections
• Site Assessment and/or Initiation visits
• Training of Clinic Trial sites (from Start up to study Close out)
• Research budget management

Clinical Research Associate:
• Assessment of research sites suitability to perform Clinical Trial (Studies)
• Initiation Visits to start the study
• Interim Monitoring visits with the purpose to evaluate and employ remedial actions
• Close out visits
• Writing of Reports (Assessment, Initiation, Monitoring and Audit)

Laboratory Auditor:
• Assessment of research laboratories suitability to perform Clinical Research Activities/Studies

Pharmacy And Regulatory Affairs:
• Assessment of research Pharmacy suitability to perform Clinical Research Activities/Studies.
• Oversight of Drugs accountabilities and Destructions
• Regulatory and Ethics Submissions and follow ups.

Good Clinical Practices:
• ICH-GCP training to research sites
• Training of research staffs on specifics of a research protocols such as Source Documentations and Regulatory Affairs
• Development of Quality Management Plan to support Research sites

Management:
• Member of interview panel for hiring new Clinical Operations staffs.
• Member of bid defence team for the selection of CROs/Vendors
• Planning of Monitoring Visits schedules
• Risk Identification/Escalation and Reports to Senior management
• Performance Review of site Monitors (CRAs)
• Oversight Quality Assessment Visit of contracted CROs/Vendors
• Facilitation and Coordination of the Study sites management
• Coordination/Supervision of site Monitors (CRAs)
• Supervision and training of Trainee CRAs
Others:
• Attended B.Tech in Pharmacy Course and Human Resources course at Twsane University in 2006 - 2007, Pretoria.
• Attended Epidemiology course in Infectious Diseases & Bioethics at WITS Medical School in Jan-March 2012.
• Attended Postgraduate Immunology Course (non-degree purpose) at University of Cape Town (UCT) Health Sciences, Immunology Department in Jan-July 2013.

EMPLOYMENT:

2000 - 2005: Tutoring students in French, Biology, Mathematics and Chemistry.

01 May 2004 – 20 Sep 2004: Lecturer at Dawnview High School in Primrose (South Africa).

24 Sep 2004 – 15 Jan 2006: Medical scientist at AMPATH laboratories - Microbiology Pomona branch (South Africa).

23 Jan 2006 – 30 Oct 2006: Research Assistant at the Hepatitis and HIV Research Laboratory and Part-time Lecturer at the University of Limpopo (Medunsa Campus) Lecturing Postgraduate students in Microbiology and Advanced Microbiology.

01 Nov 2006 – 28 Feb 2007: Contractual Laboratory Auditor. Conducted audits for PPD on a contractual basis for a laboratory participating in the HIV Prevention Trials Network (HPTN), HIV Vaccine Trials Network (HVTN), the Adult Aids Clinical Trials Group (AACTG), for the National Institute of Allergy and Infectious Diseases (NIAID) for the US government.

01 May 2007 - Mar 2010: Clinical Research Associate at Pharmaceutical Product Development (PPD-SA) contracted to the National Institutes of Health - Division of Microbiology and Infectious Diseases (NIH/DMID) for the US government.
Performs and coordinates assigned aspects of the clinical monitoring process in accordance with ICH-GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conducts site visits (Assessments, Initiations, Interim Monitoring visits, Close out Visits) to determine protocol and regulatory compliance, and prepares required documentation. Develops collaborative relationships with investigative sites and client company personnel. Research Pharmacy and Laboratory Audits. 75% of my job is traveling to research sites funded by NIH/DMID across the whole African continent.

Mar 2010 – 28 Feb 2011: Senior Clinical Research Associate at Pharmaceutical Product Development (PPD-SA) contracted to the National Institutes of Health- Division of Acquired Immunodeficiency Syndrome (NIH/DAIDS) for the US government.
Performs and coordinates assigned aspects of the clinical monitoring process in the Therapeutics Research Program (TRP) reported under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) and the Adult AIDS Clinical Trials Group (AACTG) networks, the Prevention Sciences Program (PSP) reported under the Microbicide Trials Network (MTN), the Vaccine Research Program (VRP) reported under the HIV Prevention Trials Network (HVTN) and HIV Vaccine Trials Network (HPTN) and the Basic Sciences Program (BSP) network for the Division of AIDS (DAIDS). Research Pharmacy and Laboratory Audits. 75% of my job is traveling to research sites funded by NIH/DAIDS across the whole African continent.

01 Mar 2011 – 01 Aug 2012: Lead Senior Clinical Research Associate at AERAS Global TB Vaccine Foundation. Performs and coordinates assigned aspects of the clinical monitoring processes in accordance with ICH-GCPs/Regulatory authority and IRBs/IECs rules and SOPs to assess the safety and efficacy of AERAS TB vaccines candidates currently under clinical trials globally. Provide training supports i.e. Protocols, ICF, Quality Management Plan, Source documentations, Site Trainings, etc. to selected sites. Research Pharmacy and Laboratory Audits. Furthermore, in countries where the monitoring activities are performed by a client company (Clinical Research Organization), supervise and coordinate the client company Clinical Research Associate activities with regards to the trial requirements.
01 Aug 2012 – 15 Feb 2013: Oversee CRAs activities, in addition responsible for CROs oversights (Quality Assessment Visit) to ensure approved Quality Management Plans are followed. Review and approval of Site Monitoring reports and Quality Assessment Reports, Site Budget negotiation and Support to Protocol Director/Director of Clinical Operations. Lead CRA for co-sponsored TB vaccine study (Aeras and GSK) and performed pre-site assessment visits, site selections and sites budget negotiation. Member of the Aeras team to select for the winning Bidding CROs for Lab activities and Protocol monitoring contracts.

18 Feb 2013 – 09 Aug 2013: Senior Clinical Research Associate at ClinTec International. Contracted to Novartis Vaccines and Diagnostics (NVD). Performs and coordinates assigned aspects of the clinical monitoring process in accordance with ICH-GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conducts site visits (Assessments, Initiations, Interim Monitoring visits, Close out Visits) to determine protocol and regulatory compliance, and prepares required documentations. Research Pharmacy and Laboratory Audits. Oversee sites payment based on completed monitored visits. Manage the day-to day- site requirements and trainings in line with approved Protocol procedures. Develops collaborative relationships with investigative sites and client company personnel.

12 Aug 2013 – 15 Aug 2014: Senior Clinical Research Associate at Safrimed. Contracted to Sanofi-Aventis. Performs and coordinates assigned aspects of the clinical monitoring process in accordance with ICH-GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conducts site visits (Assessments, Initiations, Interim Monitoring visits, Close out Visits) to determine protocol and regulatory compliance, and prepares required documentations. Oversee sites payment based on completed monitored visits. Research Pharmacy and Laboratory Audits. Manage the day-to day- site requirements and trainings in line with approved Protocol procedures. Develops collaborative relationships with investigative sites and client company personnel.

15 Aug 2014 – To date: Consultant Senior Clinical Research Associate and Project Manager. Conduct all CRAs activities such as Feasibility, Regulatory Submissions, Quality Assessment Visits, Initiation Visits, Interim Monitoring Visits, Close Out visits and Visit Reports, Laboratory and Pharmacy Audit Visits. Provide Project Management support as well as site Personnel Training. Ensure Quality Management Plans are followed. Provide Oversight activities when external CROs are used by Reviewing and Approving Site Monitoring Reports and to support Protocol Director/Director of Clinical Operations as applicable.
CLINICAL TRIAL EXPERIENCE

Genitourinary: A phase III, controlled, randomised, multi-center, two-arm study to evaluate the effectiveness of two Antiretroviral Therapies to prevent the sexual transmission of HIV-1 in serodiscordant couples.

Digestive System: An observational, non-randomised, single centre, study to evaluate differences and similarities of H. pylori genotype isolated from children and adults.

Cardiovascular: A phase III, double-blind, controlled, randomised, multi-center, parallel group study to evaluate the efficacy and safety of a Hypercholesterolemia therapy in High Cardiovascular Risk Patients Not adequately controlled with their Statin Therapy.

Cardiovascular/Metabolic diseases: A phase III, double-blind, randomized, placebo-controlled, parallel-group, multi-centre study to evaluate cardiovascular outcomes during treatment with type 2 diabetic patients (T2DM) after an Acute Coronary Syndrome event.

Infections/ Parasitic Diseases: A phase I, double-blind, controlled, randomised, single centre, dosage-escalation study to evaluate the safety, immunogenicity, reactogenicity of Malaria vaccine in semi-immune healthy adults.

Infections/Parasitic Diseases: Open-label, longitudinal, randomised, single centre, study to evaluate multi-drug efficacy among children who present with uncomplicated ...

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