Summary
Overview
Work History
Education
Skills
Educationalbackground - Tertiaryeducation
Certification
Personalreference
Health
Postaldetails
Contactdetails
Personal Information
Languages
Jogging, Working Out, hiking and Trying out new cooking recipes
Timeline
Generic

BOIKANYO Boikanyo

Quality Improvement Advisor
Johannesburg

Summary

To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.

Overview

13
13
years of professional experience
3
3
Certifications

Work History

Internal Monitor(AD-HOC)

Ezintsha
08.2022 - Current
  • Review and verify CRF’s and source documentation to ensure accuracy and completeness and compliance with applicable regulations
  • Identify trends of inconsistencies and deviations to the requirements and regulations listed above
  • Document findings relating to the monitoring of CRF’s and source documents by completing SDV forms and disseminate these findings to the appropriate clinical staff
  • Ensure that SDV forms are returned timeously and include adequate documentation that findings have been resolved appropriately
  • Assist in reviewing specified records prior to site audits by DAIDS contract monitors or inspections by other regulatory bodies
  • Review Quarterly Site Monitoring Reports generated by DAIDS contract monitors to assist in identifying trends and errors in completing CRF’s and source documents and apply this knowledge to improve subsequent monitoring
  • Generate monthly monitoring reports that included a quantitative and qualitative review of source documentation and CRF’s monitored
  • Ensure site readiness for new protocols
  • Develop tools and source documents to ensure protocols are adhered to and smooth collection of required data
  • Identify substandard performance by team members and take necessary corrective action
  • Coach and train subordinates and team members to ensure the acquisition of knowledge and skills required by the organization Required minimum education and training
  • Human subjects’ protection training Certificate
  • Member of South African Clinical Research Association (SACRA)
  • SA-GCP and ICH-GCP
  • Sound knowledge of good clinical practice
  • An ability to work independently in a team and be pro-active
  • Assist in study start Up
  • Assisting in acquiring CRO contracts ,External Medical Officer and Auditing Contracts for Investigator Sponsor Led studies
  • Maintaining Confidential Disclosure Agreements for ne studies
  • Partake in site activation process

Quality Improvement Advisor

Ezintsha
05.2022 - Current

Verify correctness and completeness of ALL source documentation
Ensure errors on source documents and timeously (within 24hours) corrected, initialled, and dated by the authorized signatory
Assist in completion of corrective action for internal monitoring reviews - coordinate staff training (and retraining) where error trends are identified
Assist with the review and revision of standard operating procedures per study specific needs as needed
Assist in electronic data clarification queries
Perform 100% QC of all ICF documentation and maintain tracking log
Resolve laboratory errors by timeously generating or responding to DCFs
Review and verify CRF’s and source documentation to ensure accuracy and completeness and compliance with applicable regulations.
Identify trends of inconsistencies and deviations to the requirements and regulations listed above.
Document findings relating to the monitoring of CRF’s and source documents and disseminate these findings to the appropriate clinical staff.
Ensure that monitoring reports are returned timeously and include adequate documentation that findings have been resolved appropriately.
Assist in reviewing specified records prior to site audits by external monitors or inspections by other regulatory bodies.
Review Site Monitoring Reports generated by external monitors to assist in identifying trends and errors in completing CRF’s and source documents and apply this knowledge to improve subsequent monitoring.
Ensure site readiness for new protocols
Develop tools and source documents to ensure protocols are adhered to and smooth collection of required data.
Develop and review essential study specific documents (e.g.: SOPs, Protocol, source documentation and lab forms).
Produce relevant weekly reports according to project needs
Support the ordering and control of consumable stock
Support inventory and calibration of clinical equipment
Timely reporting of study statistics to the study PI and team.
Assist with efficient clinic flow activities
Take ownership and accountability for tasks and demonstrates effective self management.

Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained.
Maintain a positive attitude and respond openly to feedback.
Take ownership for driving own career development by participating in ongoing training and development activities such as conferences, workshops etc.
Able to work independently and as part of a team, confident to lead study QA activities from start-up to closure.

Quality Control Officer

Ezintsha
05.2021 - 04.2022
  • Verify correctness and completeness of ALL source documentation
  • Ensure errors on source documents are corrected within 24 hours
  • Assist in completion of corrective action for internal monitoring reviews
  • Assist with the review and revision of standard operating procedures
  • Assist in electronic data clarification queries
  • Perform quality control of all ICF documentation and maintain tracking log
  • Ensure correctness and completeness of laboratory specimens and applicable forms before sending to the lab
  • Resolve laboratory errors
  • Facilitate resolution of external monitoring queries.

Quality Control/Quality Assurance Officer

AURUM INSTITUTE
10.2020 - 04.2021
  • Conduct in-house monitoring to ensure compliance with ICH/GCP, standards, Protocol and other Guidelines
  • Ensure staff are using current versions of study documents
  • Data verification of source data and relevant documents
  • Sample QC
  • Give ongoing feedback on findings/trends
  • Identify training needs and give feedback to relevant personnel
  • Develop and maintain systems for collecting correct data
  • Resolve study-related queries
  • Review project developed source documentation
  • Provide training on quality-related topics
  • Prepare for monitoring visits
  • Review corrective/preventive actions
  • Assist in implementing the Quality Management Plan
  • Perform other delegated duties
  • Ensure version control of study documents
  • Ensure timely reporting of project activities
  • Perform quality control of recording and reporting procedures
  • Apply national and international research legislation.

Research Assistant (Social Science Interviewer)

AURUM INSTITUTE
10.2020 - 04.2021
  • Conduct outreach activities
  • Explain and answer questions about the research to potential volunteers and stakeholders
  • Recruit and screen volunteers through social science interviews
  • Provide feedback on recruitment strategies
  • Maintain confidentiality and ethical standards
  • Administer screening questionnaires
  • Document counselling sessions
  • Assist with volunteer enrollment
  • Provide risk-reduction counselling
  • Retain volunteers
  • Obtain and update locator data
  • Follow up with participants
  • Recommend retention strategies
  • Ensure completion of study documentation
  • Complete and submit study case report forms and source documents
  • Report on daily/weekly activities
  • Assist with SOP development
  • Participate in training and meetings.

Quality Control Officer

CAPRISA
02.2020 - 09.2020
  • Ensure errors on source documents are corrected within 24 hours
  • Assist in completion of corrective action for internal monitoring reviews
  • Assist with the review and revision of standard operating procedures
  • Assist in electronic data clarification queries
  • Perform quality control of all ICF documentation and maintain tracking log
  • Ensure correctness and completeness of laboratory specimens and applicable forms before sending to the lab
  • Resolve laboratory errors
  • Facilitate resolution of external monitoring queries.

Quality Control Officer

AURUM INSTITUTE
12.2018 - 01.2020
  • Conduct in-house monitoring to ensure compliance with ICH/GCP, standards, Protocol and other Guidelines
  • Ensure staff are using current versions of study documents
  • Data verification of source data and relevant documents
  • Sample QC
  • Give ongoing feedback on findings/trends
  • Identify training needs and give feedback to relevant personnel
  • Develop and maintain systems for collecting correct data
  • Resolve study-related queries
  • Review project developed source documentation
  • Provide training on quality-related topics
  • Prepare for monitoring visits
  • Review corrective/preventive actions
  • Assist in implementing the Quality Management Plan
  • Perform other delegated duties
  • Ensure version control of study documents
  • Ensure timely reporting of project activities
  • Perform quality control of recording and reporting procedures
  • Apply national and international research legislation.

Research Assistant (Social Science Interviewer)

AURUM INSTITUTE
10.2013 - 11.2018
  • Conduct outreach activities
  • Explain and answer questions about the research to potential volunteers and stakeholders
  • Recruit and screen volunteers through social science interviews
  • Provide feedback on recruitment strategies
  • Maintain confidentiality and ethical standards
  • Administer screening questionnaires
  • Document counselling sessions
  • Assist with volunteer enrollment
  • Provide risk-reduction counselling
  • Retain volunteers
  • Obtain and update locator data
  • Follow up with participants
  • Recommend retention strategies
  • Ensure completion of study documentation
  • Complete and submit study case report forms and source documents
  • Report on daily/weekly activities
  • Assist with SOP development
  • Participate in training and meetings.

Volunteer as a community care worker

Rustenburg Hospice
03.2013 - 08.2013
  • Make home visits to patients
  • Check patients' adherence to medication
  • Make referrals of community patients
  • N/A

Floor Manager

Wimpy Restaurant
01.2012 - 01.2013
  • Manage the shop
  • Stock taking
  • Ordering of stock
  • Cashing out at the end of every shift
  • Supervising the staff
  • Training new staff members.

Education

Bachelor of Science - Psychology

University Of North West
Mafikeng, South Africa
04.2001 -

Skills

Organizational skills, Interpersonal skills, data collection and Computer skills Good writing skills , good Communication Skills Highly Motivated , Result Driven Attention to detail Analytical skills Ability to work individually Ability to work in teams, ability to work under pressure, Stress tolerant , good attention to detail, Interviewing skills, Source Data Verification(SDV) ,Training , ,Regulatory Compliance, Monitoring Report Writing ,Clinical Data Management

Educationalbackground - Tertiaryeducation

  • University of South Africa, Bachelor of Arts Honors in Psychology, 2016, Psychological Assessment, Research Report, Psychopathology, Research Methodology, Development Studies, Community and Health Psychology, Ecosystematic Psychology and Therapeutic Psychology
  • University of North West, Bachelor of Social Science in Psychology Degree, 2012

Certification

Good Clinical Practice certificate

Personalreference

  • Phillip Mphahlele (QC/QA Manager), 0727416231- The Aurum Institute
  • Nondzwakazi Mqonywa (Project Manager), 0829735625/0733329261 -The Aurum Institute
  • Ineeleng Taukobong (Senior Clinical Trials manager) 072 483 081- Ezintsha

Health

Good

Postaldetails

119 7TH Road Kew, Johannesburg

Contactdetails

0607050525

Personal Information

  • ID Number: 9010020490082
  • License: Code8
  • Date of Birth: 10/02/90
  • Gender: Female
  • Nationality: South Africa
  • Marital Status: Single

Languages

English
Setswana
Advanced (C1)

Jogging, Working Out, hiking and Trying out new cooking recipes

I take up exercising as a way to alleviate stress. And cooking and Baking to make my daughter happy.

Timeline

Internal Monitor(AD-HOC)

Ezintsha
08.2022 - Current

Quality Improvement Advisor

Ezintsha
05.2022 - Current

Quality Control Officer

Ezintsha
05.2021 - 04.2022

Quality Control/Quality Assurance Officer

AURUM INSTITUTE
10.2020 - 04.2021

Research Assistant (Social Science Interviewer)

AURUM INSTITUTE
10.2020 - 04.2021

Quality Control Officer

CAPRISA
02.2020 - 09.2020

Quality Control Officer

AURUM INSTITUTE
12.2018 - 01.2020

Research Assistant (Social Science Interviewer)

AURUM INSTITUTE
10.2013 - 11.2018

Volunteer as a community care worker

Rustenburg Hospice
03.2013 - 08.2013

Floor Manager

Wimpy Restaurant
01.2012 - 01.2013

Bachelor of Science - Psychology

University Of North West
04.2001 -
Good Clinical Practice certificate
HSP certificate
Certificate in Basic Counselling
BOIKANYO BoikanyoQuality Improvement Advisor