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Summary

Worked extensively in the West Africa region from a trainee CRA to Senior CRA II. Monitored various trials for various sponsors for a period of five years. Well experienced in different aspects of clinical research and grounded understanding of all terminologies in Clinical research with a background in Pharmacy and public health studies as an added advantage. Able to work under pressure with little or no supervision. Experienced with various study protocols ranging from malaria to HIV-AIDS

Experiences

Past Experience

  • Executive Managing Director
    September 2013 --- November 2015

  • Senior Clinical Research Associate
    March 2012 --- August 2013
    PURPOSE Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. RESPONSIBILITIES • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. • Act as a mentor for clinical staff including conducting co-monitoring and training visits. • May provide assistance to the CTL with design of study tools, documents and processes.

  • Clinical Research Associate (CRA)
    June 2009 --- March 2012
    •Complete appropriate therapeutic, protocol and clinical research training to perform job duties. •Gain experience in study procedures by working with experienced clinical staff in Clinical Research Associate (CRA), Clinical Team Lead (CTL) and Clinical Trials Assist (CTA) roles. May also work collaboratively with other functional groups such as data management and pharmacovigilance. •Under close supervision, perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices. •Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues. •Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to CTL and/or line manager. •Under close supervision, manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution. •Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.

  • Pharmacist
    January 2004 --- July 2006
    · Marketing of imported and manufactured medicines of the company by way of clinical presentations to doctors and other health care professionals · Collecting orders and supplying medicines to various hospitals, clinics and pharmacy shops · Monitoring the stock levels at the warehouse and ensuring that as much as possible products do not get expired. · Coordination of monthly sales reports from sales personnel and helping them to achieve their sales targets by way of generating prescriptions from prescribers. · Organization of promotional activities

Personality

Self Assessment :
AdaptabilityApproachabilityAttention to detail

Knowledge

Self Assessment :
Clinical monitoringClinical study reportsGCPInfectious diseasesClinical trialsClinical operationsEDCICH-GCP
LinkedIn Assessment :
Clinical trialsClinical monitoringRegulatory submissionsPublic HealthRegulatory Requirements

Skills and Expertise

Self Assessment :
Create SOPs Interact with physicians Monitor a clinical studyAdverse event reportingAssist study siteComplete study procedures Develop clinical trial protocolsApprove monitoring reportsFollow-up of external audits

Education

  • M.Sc. in Management and Policy-Analysis(Specialization:International Public Health) from VU University Amsterdam in 2008
  • Bachelor of Pharmacy in Pharmacy from Kwame Nkrumah' University of Science and Technology, Kumasi in 2000

Training and Certification

  • M.Sc Management and Policy-Analysis in 2008 Certification
  • B.Pharmacy in 2000 Certification

Languages

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

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    Senior Clinical Research Associate
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position
    BrightOwl freelancer :    40 Hours per week
    BrightOwl employee
  • International:
    Yes

Area / Region

Accra, Ghana

Others

Driving License
  • Yes