Thokozani Makuhunga (Nee Nkhalamba)

Project Management

· Clinical Research Site Coordination local and internationally.

· Assist the Principal Investigator, Medical Officers and Study team in the day-to-day running of the study and manage clinic flow.

· Assist the CRS Coordinator to ensure that pharmacy have updated regulatory documents.

· Create, update and amend source documents.

· Prepare for new protocols following the protocol preparation checklist to ensure smooth run of the protocol and liaise with laboratory to receive protocol specific requisition forms, chain of custody forms and the appropriate study kits.

· Prepare the study regulatory files and liaise with laboratory to receive protocol specific requisition forms, chain of custody forms and the appropriate study kits.

Administrative

• Complete and submit pharmacy and hospital invoices for the clinical trials
• Assist the clinical coordinators, research nurses, and other hospital staff with clinical trial regulatory compliance
• Prepare and maintain consent wall folders with copies of the latest IRB approved consents for the ease of physicians seeking to enroll patients.
• Ensure that physicians are current on their IRB training and CTEP and NCI registration
• Update Cooperative Group Trials monthly accrual documents for submission
• Coordinate UAB Department of Radiation Oncology Science Hour presentations
• Complete and submit Research Summary Forms for IMPACT, Covid -19 vaccine trial, HIV prevention Trials Networks (HPTN)
• Work with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols. notification and submission of safety reports

Project Management and site administration

· Clinical Research Site Coordination local and internationally.

· Assist the Principal Investigator, Medical Officers and Study team in the day-to-day running of the study and manage clinic flow.

· Assist the CRS Coordinator to ensure that pharmacy have updated regulatory documents.

· Create, update and amend source documents.

· Collate staff documents for regulation submission, and submission of the essential documents to the relevant IRB/EC. Maintain and update the Investigator Site File including tracking and filing submissions and approvals/acknowledgments to regulatory bodies (EC, MCC, IBc & DAFF) as well as regulatory logs: protocol deviation/non-compliance log; ICF tracker; Screening & enrolment log.

· Compiling study progress reports. Monthly and annually for both clinical and community activities.

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Administration

Monitoring

· Facilitate the review of site investigator files at least once quarterly or as per project requirements ensuring all relevant documents are filed and maintained accordingly;

· Document the internal monitoring findings and circulate to all relevant stakeholders including project managers and Principle Investigator’s

· Assist with review of participant’s binders on a daily basis to ensure forms are completed correctly before the participant leave the clinic.

· Facilitate internal monitoring debrief sessions with the relevant stakeholders ensuring methods of correction are identified and set timelines for such corrections;

· Ensure thorough understanding of the project protocol, SSP manuals, SOP’’s or any other study related materials.

· Assist Project Team with the addressing and resolution of external monitor findings;

· Attend internal and external meetings as required;

· Conduct study close out meetings ensuring all respective data issues, monitoring issues, study documentation are dealt with in line with protocol;

· Ensure project close out archiving is arranged, facilitated and ensured as per project requirements.

· Prepare and timeously submit the relevant progress reports as required by sponsor in conjunction with the necessary stakeholders;

· Assist with communication with all regulatory bodies.

· Key liaison person with International Partnership for Microbicides (IPM) Auditors. Responding to queries and clarifications during the visit and report writing.

· Key point person with the Pharmaceutical Product Development (PPD) monitors during their site monitoring quarterly visits. Responding/resolving of queries and clarifications during the visit through report writing.

· Continuing communication with FHI 360 on MTN 020 protocol throughout the study period; report writing, conference calls, point person for semiannual site assessment visits.

· Budgeting on specific study budgets and identifying employees and staffing for the specific protocol.

· Involved in the protocol specific training and identifying staff training needs before, and during protocol implementation.

· Review of Protocol making sure they meet the local requirements and regulations. And identifying sections of the protocol that may require amendment during Implementation.

· Adapting Case Report Forms (CRF’s) to meet local requirements.

· Developing site specific Standard Operating Procedures (SOP’S) for specific protocols.