Lead point of contact for clinical vendors and lead the vendors at site. Track vendor invoices for accuracy and against contract and send invoices for processing and payment (local vendors)Training log for all vendors, keep training certificates and provide initial and ongoing training for new staff members.Provide weekly study status updates to project team and management as needed.Create quality management plan: Quality control, Audits planned, data documented and reported in compliance with GCP.Prepare site regulatory documents, reviewing for completeness and accuracy. (CVs, workload-evidence, qualification of the PI) Ensure data accuracy through source verification tool and escalate any issues or queries to clinical lead /CRA. Follow up with outstanding queries. Make sure documents was summited in the time frame. providing documents and reports to internal team membersRequested documents: CVs in the SAPHRA format, workload, declaration, certificates, and qualifications- check for any expired documents. (GCP certificate)Do planning for start-up meetings and make sure all essential documents in place as per ICH GCP regulation.Participates in investigator meetings and trainings.Create courier tracker for local and international shipments of supplies received at site.Update and maintain internal systems and databases Make sure correct amended documents received (Consents) Follow up the progress, the approval and execution of documents, regulatory, ethics.Sumit safety notifications to ethics and keep the site tracker up to date.Assists with coordination, compilation, and distribution of Investigator Site File and Pharmacy materials and suppliesFinancial /Budget negational: Review the budget with the PI and advice any error. Review the financial contract when submit invoices.perform Subject Data Review with source verification weekly. Interaction with CRA and follow-up on study required milestones from the project start until close out

Set up and provided guidance for a new site at Red Cross hospital•Wrote and reviewed Standard Operating Procedures (SOPs) for Informed Consent•Reviewed and performed quality control on Patient Informed Consent Forms (ICFs)•Verified ICFs against Study protocol for any amendment changes•Ensured correct version and date on all documents•Conducted training on SOPs and updated training log with staff members•Reviewed and arranged calibration for all equipment, created tracker for yearly calibration•Prepared Calibration file with details of all equipment used•Developed source documents in accordance with ECRF guidelines and protocol•Conducted review to ensure accuracy and completeness of data as per Source DataVerification•Reviewed Source Data Verification in the site files•Updated and maintained site files, including requesting updated Investigator Brochureand confirming correct version•Obtained correct Investigator approval signature in the site files•Managed deviation log and submitted to the monitor•Collaborated closely with the monitor as per provided Monitor plan schedule•Created quality management plan, including planned audits anddocumentation/reporting of data in compliance with GCP•Assisted with quality control, reviewing patient files and ensuring proper screening andhigh-quality data as per GCP•Reviewed and maintained up-to-date delegation log for new members, submitted to themonitor•Attended exit meetings with the monitor and Principal Investigator (PI)•Updated payment trackers for transportation fees and patient visit schedule fees•Reported safety events (AE/SAE) to the monitor•Supervised site financial management and ensured compliance with the clinical trialagreement•Followed up on invoices for timely payments

Regulatory compliance with GCP and compliance with sponsor requirements. Work very closely with Country Regulatory Affairs and SAPHRAMaintain and update the Investigator Site File. /Preparation for A Submissions to Ethics/ prepare the site for site selections for New studies. Keep good correspondence with the Sponsors.Review documents for completeness, consistency, and accuracy. Update and maintain internal systems, databases, timelines with accurate and complete project information.Assist and preparations for start-up (SIV) meetings for new studies. Check pre-study checklist according to the SOP., Study setup preparation and control of study material and resources.Well -trained in quality control management for preparations: Informed consents, source.Regular Training in meetings for new / updated SOP /review and update of SOP. Maintains knowledge of and understands SOPs and sponsor SOPscurrent regulatory guidelines as applicable to services provided.Keep pre-site selections meetings with CRA/Sponsors Arrange SIV meetings and update CRA CRA/Sponsors train certificates and make sure delegation log and training logs are completed with SIV.Perform trial close out visits and send all trial material to sponsor.

Scrutinized Claims accounts, analyzing ICD10 codes, length of stay, and level of care.•Accurately coded diagnosis and procedures.•Sent communication to service providers.•Counseled and educated members and their families.•Provided advice to doctors on correct ICD10 coding, staying updated on daily updates ofICD10 codes.•Ensured correct application of co-payment, both automated and manual.•Monitored daily quality care in the hospital and assisted patients with their needs.•Facilitated referral to appropriate, cost-effective facilities based on available benefits.•Ensured compliance with hospital rules regarding exclusions and escalated issues whennot automated.•Identified emergencies using clinical knowledge and clinical data.•Managed escalation procedures.•Maintained accurate records and documentation of patient and clinical data.•Received continual training and updated skills and knowledge related to call center andcase management, including negotiation and assertiveness skills, understanding ofclinical coding, familiarity with different hospital tariffs, and knowledge of hospital claimsand charges.•Collaborated closely with the infection control coordinator regarding patients withinfectious diseases.

attend daily ward round to update medical progress, treatment plan, change in condition. Liase with Top management to ensure quality patient care. Keep logs of infection disease, monitor and rapport to Management.Be part of planning of fire drills, Mass emergencies, Bomb scare. Keep planning log updated.Keep updated Patient admission list: How many disability patients and Mental health Patient in the ward. Promote direct and indirect health care for Psychiatric pts. Monitor to prevent abscondence of patients. Refer Psychiatrics patient with Auth. Complete the necessary forms. Lead investigation for absconded pts:.

Managed assigned studies, overseeing regulatory submissions, recruitment, CRFcompletion, and data query resolution.Margo Botha margo.botha@gmail.com 5 / 6•Ensured smooth clinic operations, including patient bookings, file preparation, and properlab result filing.•Assisted with patient referrals and incidents, evaluating and providing inservice trainingas needed.•Promoted a safe environment for patients and their belongings.•Addressed and resolved patient complaints, conducting regular discussions with the teamfor improvement.•Managed equipment inventory and provided in-service training on equipment usage.•Enforced disciplinary action policies and maintained open communication with staffmembers.•Ensured proper training for staff and adherence to scope of practice and delegated tasks.

Responsible for the background administration and trial set up,monitoring, tracking and close out meetings. Maintenance of project files and documentation in an orderlymanner according to relevant SOPs and WPDsProvide general administrative support to project team members,and ensure that project related administrative tasks are carried out.Reports monthly on project updates by using the designated communication dashboards.Monitors the regulatory submissions and approvals and keep open c Work very closely with Country Regulatory Affairs and SAPHRA communications