Katlego Crishelda Modiba
Study Coordinator
Johannesburg,Gauteng
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
2
2
years of professional experience
Work History
Regulatory and Quality Administrator
Clinical Research Investigator Site Management Organization (CRISMO)
10.2022 - 01.2023
- Leading regulatory communications, adherence, and regulatory file review.
- Performing regulatory submissions.
- Ensuring all queries are attended to on a timely manner.
- Ensuring staff members always follow the standard operating procedures(SOPs) and GCP.
- Discussing QC trends with the study team during team meetings, and conducting refresher training where
needed. - Ensuring understanding of project protocol and SSP manual.
- Maintaining positive and constructive feedback, provision of assistance, and active problem solving.
- Participate in project team meetings, provide constructive feedback and support to team members.
- Conducting quality control activities monthly on participant files, and train site personnel on the
protocol. - Demonstrated strong organizational and time management skills while managing multiple projects.
- Proven ability to learn quickly and adapt to new situations.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
- Paid attention to detail while completing assignments.
Quality Control Officer
Clinical Research Investigator Site Management Organization (CRISMO)
03.2022 - 01.2023
- Documented QC results by completing logs.
- Monitored over three study projects and complied with specifications and regulatory requirements.
- Conducted investigations into questionable source notes.
- Ensuring understanding of project protocol and SSP manual.
- Participate in project team meetings, provide constructive feedback and support to team members.
- Conducting quality control activities on a daily basis on participant files, and train site personnel on the non-clinical sections of the protocol.
- Assisting with regulatory communications, adherence, and regulatory file review.
- Ensuring all queries are attended to on a timely manner.
- Ensuring staff members always follow the site standard operating procedures(SOPs) and GCP.
- Discussing QC trends with the study team during team meetings, and conducting refresher training where needed.
- Maintaining positive and constructive feedback, provision of assistance, and active problem solving.
Study Coordinator
Clinical Research Investigator Site Management Organization
09.2021 - 01.2023
- Worked on COVID prevention vaccine studies (both adults and pediatrics), Cardiovascular treatment vaccine studies, Respiratory virus prevention vaccine studies, Hepatitis B study, and TB observational study.
- Used the Real-Time system to schedule study visits.
- Worked with the following electronic data capturing systems: iMedidata Rave and Inform.
- Experience in using SIP, Firecrest,Signant Health, and TrialMax.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Followed informed consent processes and maintained records.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Provided professional services and support in a dynamic work environment.
- Skilled at working independently and collaboratively in a team environment.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Reduced study attrition rates by proactively addressing participant concerns and providing ongoing support.
Study Coordinator
Setshaba Research Centre
02.2023 - 02.2024
- Have coordinated HIV prevention vaccine studies (including HVTN and PrEP studies) and Respiratory virus studies (includes Maternal and Pediatrics studies).
- Experience in using the following electronic data capturing systems: iMedidata and Inform.
- Experience in using the following IRT systems: Suvoda and Signant Health.
- Experience in using Firecrest, SIP, Florence, and Ripple.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Ensured regulatory compliance by meticulously maintaining documentation for study activities.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Skilled at working independently and collaboratively in a team environment.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Followed informed consent processes and maintained records.
Education
Bachelor of Science - Science
University of Johannesburg
Johannesburg 04.2001 -
High School Diploma -
Luthuli Park High School
Limpopo 04.2001 -
Skills
Informed Consent process
Scheduling Proficiency
Good Clinical Practices
Report Preparation
Participant Screening
Trial Management
Documentation Requirements
Research SOPs Understanding
References
Name: Kgaogelo Molapo
Position: Study Coordinator HoD at Setshaba Research Centre
Email Address: kmolapo@setshaba.org.za
Cellphone Number: 073 414 6497
Name: Zanele Mabizela
Position: Former Regulatory Lead and Study Coordinator at CRISMO
Email Address: zmbizela@outlook.com
Cellphone Number: 060 300 7019
Name: Dr Morakane Makwela
Position: Medical Officer at Setshaba Research Centre
Email Address: MMakwela@setshaba.org.za
Cellphone Number: 071 426 0535
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Study Coordinator
Setshaba Research Centre
02.2023 - 02.2024
Regulatory and Quality Administrator
Clinical Research Investigator Site Management Organization (CRISMO)
10.2022 - 01.2023
Quality Control Officer
Clinical Research Investigator Site Management Organization (CRISMO)
03.2022 - 01.2023
Study Coordinator
Clinical Research Investigator Site Management Organization
09.2021 - 01.2023
Bachelor of Science - Science
University of Johannesburg
04.2001 -
High School Diploma -
Luthuli Park High School
04.2001 -