Summary
Overview
Work History
Education
Skills
Websites
Certification
Languages
References
Work Availability
Timeline
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Maurice Okello

Maurice Okello

Clinical Research Associate
Nairobi

Summary

A clinical research professional with 5 years' experience, well-versed with clinical trials regulations such as ICH-GCP guidelines, local regulatory authority and IRB approval requirements, study start-up, safety monitoring, risk-based monitoring, data quality monitoring, source data review and verification. I aim to work with teams where my expertise, experience, dedication, leadership and responsibility can be thoroughly utilized, hence contributing to the advancements in the clinical trials filed.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Internal Monitor

KEMRI/University of Washington
Nyanza
08.2019 - 11.2023
  • Reviewed all adverse event reports for accuracy and completeness prior to submission to the Sponsor or Regulatory Authority.
  • Provided efficient and accurate data entry for clinical research studies, including entering patient information into databases.
  • Assisted in preparation of study-related materials such as CRF completion guidelines, informed consent forms, according to ICH and GCP standards.
  • Tracked progress of each study by reviewing enrollment numbers on a regular basis and provide updates as needed.
  • Reviewed source documents, case report forms, and other pertinent documents in accordance with ICH-GCP guidelines.
  • Participated in training sessions for new employees on GCPs and SOPs.
  • Compiled monthly progress reports summarizing all activities completed during each review period.
  • Determined strategies fro research participants' recruitment and retention throughout their trials' participation.
  • Performed quality assurance checks on data entered into electronic databases.
  • Collaborated with research team members to develop strategies for collecting patient data from medical charts or electronic health records.
  • Reviewed participants' medical records to track and report adverse events and any protocol deviations.

Clinical Research Laboratory Officer

KEMRI/University of Washington
Nyanza
07.2018 - 11.2023
  • Managed daily operations within the laboratory including scheduling personnel shifts and assigning tasks.
  • Maintained a safe working environment by adhering to relevant health and safety standards.
  • Developed standard operating procedures for the maintenance, calibration, and operation of laboratory equipment.
  • Processed orders for lab supplies based on current needs in order to ensure adequate stock levels at all times.
  • Evaluated test results against established standards to identify any discrepancies or irregularities.
  • Documented all experiments conducted in the laboratory in accordance with good laboratory practice guidelines.
  • Organized and monitored inventory levels of lab supplies, reagents, and materials.
  • Performed quality control checks on results prior to reporting them to senior staff members.
  • Ensure all equipment are maintained according to manufacturer's instructions and study specific SOPs
  • Provided technical support to research teams on experimental design and methodology implementation
  • Conducted hazardous waste management activities according to safety regulations
  • Participated in team meetings to discuss ongoing projects and provide feedback on progress made thus far
  • Assist with the development of new methods for sample preparation and testing processes.
  • Record data accurately in laboratory notebooks following study protocols and SOPs.
  • Electronic data capture.
  • Data query resolution.
  • Review of Case Report Forms and Generating queries.

Medical Laboratory Officer

Nyumbani Diagnostic Laboratory
Nairobi
01.2018 - 06.2018
  • Conducted tests on biological samples to detect abnormalities or diseases
  • Analyzed results and reported findings accurately to supervisors
  • Established or monitored quality assurance programs or activities to verify accuracy of laboratory results
  • Managed inventory levels for reagents, supplies, and other consumables used in the lab
  • Ensured accuracy of laboratory techniques through calibration checks, verification processes, and troubleshooting methods
  • Performed routine maintenance on laboratory instruments and equipment
  • Collected and studied blood samples to determine number of cells, morphology and blood group
  • Developed protocols for laboratory procedures, including safety measures and quality control standards
  • Facilitated training sessions for new hires regarding proper usage of lab equipment
  • Maintained detailed records of all test results, data analysis, and other related information
  • Assisted in the preparation of laboratory equipment and materials for experiments
  • Entered data from analysis of medical tests or clinical results into computer for storage
  • Complied with regulatory requirements while performing daily tasks in the lab
  • Collaborated with colleagues to ensure efficient workflow within the lab environment
  • Protected patients and employees by adhering to infection control policies and protocols
  • Identified discrepancies between expected outcomes of experiments and actual results obtained.

Education

Master of Science - Epidemiology and Biostatistics

Jomo Kenyatta University of Agriculture and Technology

Bachelor of Science (B.S.) - Medical Laboratory Science and Technology

University of Nairobi
12.2016

Skills

  • Planning and conduct of Monitoring Visits
  • Risk-based Monitoring
  • Remote Monitoring
  • Patient Safety Monitoring
  • Regulatory compliance
  • Detailed documentation
  • Data management
  • Team Training
  • Report Writing
  • Protocol Adherence Monitoring and deviations reporting
  • Site operations
  • Data review and verification
  • Product inventories, storage and dispensing procedures monitoring
  • Adverse event documentation
  • Enrollment oversight
  • Informed consent
  • ICH-GCP compliance monitoring
  • SOPs development, review, training and assessment of compliance
  • Effective communicator with strong interpersonal skills
  • Ability to build and maintain good working relations with team members
  • Possess strong commitment to team dynamics with the ability to contribute expertise and follow any directives at appropriate times
  • Flexible team player who thrives in environments that require the ability to effectively prioritize and juggle multiple concurrent tasks Positive, resilient, and open to new ideas
  • Highly organized individual who can work and plan for efficient and productive results
  • Ability to identify possible solutions to arising situations Able to make proper judgment on complex issues
  • Proven ability to lead and manage team operations to deliver on the objectives of the organization and meets approved service standards

Certification

  • Clinical Trials Monitoring- ClinWin Research Services
  • Monitoring and Evaluation – University of Washington Global Health Learning Program
  • International Computer Driving License – Institute of Advanced Technology

Languages

English
Swahili

References

  • Edgar Kagali, Clinical Research Associate, IQVIA, +254 729 421 482, edgar.kagali@iqivia.com
  • Mary Amondi, Clinical Operations Specialist, IAVI, +254 729 421 482, mary.amondi@yahoo.com
  • Elizabeth Akinyi Ouma, Clinical Research Associate, IQVIA, +254 705 882 055, eakinyi2009@yahoo.com

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Internal Monitor

KEMRI/University of Washington
08.2019 - 11.2023

Clinical Research Laboratory Officer

KEMRI/University of Washington
07.2018 - 11.2023

Medical Laboratory Officer

Nyumbani Diagnostic Laboratory
01.2018 - 06.2018

Master of Science - Epidemiology and Biostatistics

Jomo Kenyatta University of Agriculture and Technology

Bachelor of Science (B.S.) - Medical Laboratory Science and Technology

University of Nairobi

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Maurice OkelloClinical Research Associate