Katlego Sebesho

• Manage all aspects of projects/studies from Start-up, Maintenance to Archiving phase;

Start-Up & Regulatory

• Create and submit all Regulatory Documents SAHPRA (ie CV's, Declarations, Workloads etc).
• Submit to local ethics bodies IRB/EC, maintain relevant correspondence, acquire and follow up on approvals, notifications and acknowledgements.
• Update and supercede staff certificates.
• Ensure safe keeping of all study documents by filing (i.e signed and approved Study Protocol, Regulatory Approvals, Clearance Certificate, Agreement Letters, Investigator Brochures, Monitoring Reports, Financial Disclosures etc).
• Create and update Source (CRF) documents.
• Negotiate budgets and manage study related finances.
• Ensuring that study and staff documents are submitted timeously.

Maintenance & Quality

• Coordinate between Sponsor/CRO,Investigators and clinical/site staff.
• Maintaining and Updating Site Investigator Files.
• Monitor and Report AEs/SAEs.
• Record and Maintain all correspondence (i.e Note to Files, CAPA's, Protocol Deviations).
• Maintain Logs (i.e screening,enrollment,protocol deviation,drug accountability).
• Ensure source is suited to and relevant to each visit and all procedures have been concluded.
• Review Participant Files.
• Manage Participant Compliance.
• Quality Control, Source Data Verification.
• Data Entry and facilitation of queries.
• Create and Manage Study Trackers (i.e constantly update tracker with study related information as the study progresses).
• Manage Participant Compliance and coordinate retention activities.
• Coordinate Close Out procedures and archiving processes.
• Therapeutic Area Experience: Viral Diseases; HVTN - Phase II, III, IV. HIV - Phase II, III, IV. Respiratory Diseases; TB - Phase III, IV. Maternal RSV, Phase II

• Feasibility.
• Coordinated feasibilities from CRO; compiling, completing and submitting feasibilities.
• Liaise and communicate between Sponsor/CRO's to Network/Affiliate sites.
• Liaising with Network/Affiliate sites.
• Redacting i.e Protocol Summaries, Feasibility Questionnaires/Surveys.
• Regulatory.
• Creating, updating and submitting Regulatory Documents (SAHPRA CV's, Declarations, Workloads etc), managing and tracking DOH applications.

• Log patient tests onto Lab systems i.e. MediTech.
• Prepare, organize and distribute lab results.
• Collect specimen during hospital rounds.
• Label and distribute specimen according to Lancets SOP.
• Administrative work (prepare and scan patient forms onto lab system).

• Invigilate and setting up for online tests/examinations.