Florence Abok
Clinical Research Asociate
Kampala,Central
Summary
Accomplished Clinical Research Associate with 5 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with GCP, study-specific requirements and clinical monitoring plans. In-depth knowledge of Pharma procedures, regulatory requirements and quality standards. offering advanced planning, problem solving and communication skilles developed over 5 years of clinical research success.
Overview
5
5
years of professional experience
Work History
Clinical Research Associate, Remote
FIND Diagnostics
01.2021 - Current
- Worked independently and proactively to plan and conduct various site visits (feasibility, site selection,Iniciation visits, interim and close-out) in accordance with ICH-GCP
- Managed sponsor generated queries efficiently and took responsibility for study cost effectiveness; I will also participated in the preparation and review of study documentation and feasibility studies for new proposals as required.
- Proficient in monitoring data in clinical research data base such as open clinica, Redcap, Veeva vault and CTMS.
- Prepared investigator meetings, coordinated the timely shipment and the subsequent storage and accountability of clinical supplies and followed up IP safety issues.
- Ensured integrity of clinical data through my ability to sufficiently maintain site tracking records and work diligently to relevant guidelines
- Provide support to the Project Manager / Country Manager with ad-hoc tasks as required
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Supported development and delivery of department training to maximize success of clinical research.
Lead Monitor
MSF Epicenter Mbarara Research Centre
09.2018 - 12.2020
- Performed clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations and associated documents.
- Participated & provided inputs on site selection and validation activities.
- Performed remote and on-site monitoring & oversight activities using various tools to ensure that data generated at site are complete, accurate and unbiased and Subjects’ right, safety and well-being are protected
- Conducted site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and recorded clear, comprehensive and accurate visit & non-visit reports appropriately in a timely manner.
- Communicated with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identified, assessed and resolved site performance, quality or compliance problems as per CRA Escalation Pathways in collaboration with the Epicentre clinical director
Education
Clinical Research Coordination - Clinical Research Coordinators Course
CENTRE FOR INNOVATIVE DRUG DEVELOPMENT & THERAPEUT
Addis Ababa, Ethiopia04.2022
Master of Science - Epidemiology And Biostatistics
JOOUST
Bondo, Kenya12.2018
Bachelor of Science - Public Health
Clarke International University
Kampala Uganda01.2012
Skills
- Informed Consent Monitoring
- Initiation,Interim and close out, Monitoring Visits
- Patient Recruitment Strategies
- Protocol Development
- Team Training
- Database Monitoring on Redcap, Openclinica, Veeva vault and CTMS
- Available for up to 65% of travel
- Excellent oral and written communication skills
- Experienced across a wide range of clinical indications / therapeutic areas
- A working knowledge of drug development process,ICH-GCP guidelines and local requirements
- Trip Reports
- Quality Control
- Protocol Adherence
- Research and Development
- Drug Development
- Clinical Research Monitoring
- Developing Study Tools
Affiliations
- Member, Association of Clinical Research Professionals
- Member Research Quality Asociation, membership no. 00067619
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
The way to get started is to quit talking and begin doing.
Walt Disney
Timeline
Clinical Research Associate, Remote
FIND Diagnostics
01.2021 - Current
Lead Monitor
MSF Epicenter Mbarara Research Centre
09.2018 - 12.2020
Clinical Research Coordination - Clinical Research Coordinators Course
CENTRE FOR INNOVATIVE DRUG DEVELOPMENT & THERAPEUT
Master of Science - Epidemiology And Biostatistics
JOOUST
Bachelor of Science - Public Health
Clarke International University
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