About

I am a highly regarded, versatile Clinical Trials Expert with broad experience in the clinical industry as a Regulatory Officer, Quality Assurance Officer, Quality Control Officer, Nurse Counsellor Supervisor, Research Nurse Counsellor and Study nurse; over the past 13 years. I have an outstanding record of managing the following aspects of clinical trials, including adherence to Kenya Pharmacy and Poisons Board regulations, GCP guidelines, protocol and conduct requirements, ICH guidelines and standard operating procedures. I have been instrumental in selecting, leading and motivating personnel to achieve the highest level of integrity, sensitivity and accuracy in their work. I am flexible to travel to destinations to carry out my roles and responsibilities. Having strong computer skills, I am familiar with current electronic data capture technology and have used a range of databases with consistent success in different situations. Exceptionally organised and have excellent communication, time management and team leadership skills. Driven by a determination to complete tasks successfully by flexible team leadership, I have achieved this by building and maintaining close relationships, leading by example and inspiring and mentoring colleagues. Having gained valuable experience in my previous positions, I can offer astute judgment, dedication and subject knowledge combined with a proven ability to deliver successful outcomes. I am looking for a position at a higher level where my expertise and experience would add considerable value.

Skills

  • Nursing skills
    10
  • Research regulatory skills
    10
  • Research site monitoring skills
    8
  • counseling
    10
  • English
    10
  • Kiswahili
    10
  • Luhya
    10

Experience

ELIZABETH AMBULULI

Work experience
  • Conducted site visits, including pre-study initiation and internal monitoring, to ensure ICH/GCP compliance and data integrity.
  • Assisted with the development and administration of study timelines and budgets.
  • Participated in discussions and meetings with clinical operation personnel for study-related matters.
  • Reviewed and edited key study documents such as protocols, informed consents, and investigator's brochures.
  • Provided ongoing training on study procedures, safety monitoring/reporting requirements, and data management activities.
  • Managed the filing of study-related information and prepared for regulatory audits.

ELIZABETH AMBULULI

Work experience
  • Coordinated study activities and followed study protocols to ensure accurate data collection.
  • Conducted assessments and treatments of pregnant women and newborns according to study protocol.

ELIZABETH AMBULULI

Education
  • September, 2012 - November, 2014
  • Fulltime

ELIZABETH AMBULULI

Work experience
  • November, 2010 - January, 2014
  • Fulltime
  • Monitored study team compliance with required study procedures and GCP standards.
  • Assessed and ensured subject safety throughout participation in the trial.
  • Assisted in monitoring of adverse events and maintained documents as required by regulatory agency guidelines.
  • Oversaw data entry on CRFs and audited records for accuracy and completeness.
  • Trained staff on quality control issues and resolved data queries.

ELIZABETH AMBULULI

Work experience
  • October, 2009 - December, 2009
  • Fulltime
  • Collected urine and blood specimens for HIV/STI testing and conducted voluntary counseling and testing.

ELIZABETH AMBULULI

Work experience
  • November, 2008 - October, 2010
  • Fulltime
  • Obtained informed consent from study participants and collected medical and social history.
  • Reported adverse events and conducted data and specimen collection activities.
  • Dispensed and accounted for drugs provided to participants.

ELIZABETH AMBULULI

Work experience
  • Additional nursing and counseling experience in various healthcare settings (Mar 2005 - Nov
  • 2008) provided valuable skills in patient care, communication, and teamwork, which will contribute to success as a Clinical Research Associate.

ELIZABETH AMBULULI

Education
  • March, 2001 - September, 2004
  • Fulltime

Related persons

NGOJE DUNCAN OCHIENG'Medical Laboratory Technologist at Kenya Medical Research Institute/Research Care and Training Program (KEMRI/RCTP)
Martin WasunaOffice Manager at Diana Ateka & Co. Advocates
Anne MisikoRegistered nurse at County Government of Kakamega