Open to opportunities

Thokozani Makuhunga

@thokozanimakuhunga

Message

Experienced Clinical Research Site Coordinator with a strong healthcare background.

Malawi

Message

What I'm looking for

I seek a role that allows for professional growth, collaboration, and impactful healthcare research.

I am a dedicated Clinical Research Site Coordinator with extensive experience in managing clinical trials and observational studies across South Africa and Malawi. With a Master's degree in Health Research from Lancaster University, I have successfully coordinated over 35 clinical trials, ensuring compliance with NIH and DAIDS regulations while maintaining high standards of quality and ethics in research.

Throughout my career, I have demonstrated strong leadership and organizational skills, managing multiple projects and collaborating effectively with principal investigators and sponsors. My role involves developing site-specific Standard Operating Procedures, training staff, and ensuring adherence to ICH-GCP and FDA regulations. I take pride in my ability to troubleshoot and resolve study-related issues, contributing to the successful completion of trials and the advancement of healthcare research.

My commitment to continuous improvement and professional development is evident in my proactive approach to staff training and my participation in leadership training programs. I possess excellent communication skills, which facilitate effective collaboration with both local and international stakeholders. I am eager to leverage my expertise in clinical research to contribute to impactful healthcare initiatives.

Experience

Work history, roles, and key accomplishments

Current

Clinical Research Site Coordinator

Current

University Of North Carolina Project, UNC

Jan 2020 - Present (5 years 4 months)

As a Clinical Research Site Coordinator, I facilitate daily trial activities for DAIDS sponsored studies, ensuring compliance with research protocols. I develop site-specific SOPs, maintain compliance, and manage staff training. My role includes coordinating clinical trial activities and troubleshooting study-related issues.

Clinical Research SOP Development Compliance Management Staff Training Data Management Communication Skills Problem Solving Quality Assurance Regulatory Compliance

Clinical Research Site Coordinator

Perinatal HIV Research Unit (PHRU)

Nov 2017 - Jan 2020 (2 years 2 months)

Managed clinical research site operations, ensuring adherence to regulatory requirements and effective project management. I coordinated with study teams, maintained investigator files, and compiled progress reports for multiple clinical studies.

Project Management Regulatory Compliance Data Collection Communication Skills Time Management Problem Solving Quality Assurance

Internal Monitor

Perinatal HIV Research Unit (PHRU)

Apr 2017 - Oct 2017 (6 months)

Conducted internal monitoring of clinical trial sites, ensuring compliance with protocols and documentation standards. I facilitated debrief sessions and assisted project teams in addressing external monitoring findings.

Compliance Documentation Management Communication Skills Problem Solving Stakeholder Engagement Data Management Quality Assurance

Co-Investigator/Research Study Coordinator

University of North Carolina

Sep 2012 - Dec 2014 (2 years 3 months)

Served as a key liaison for the Microbicide Trials Network, managing study protocols and ensuring compliance with regulatory standards. I facilitated communication with stakeholders and developed SOPs for specific protocols.

Regulatory Compliance SOP Development Data Management Training Quality Assurance Problem Solving

Study Clinician

University of North Carolina

Jun 2002 - Apr 2007 (4 years 10 months)

Ensured data completeness and compliance with clinical procedures while managing participant retention strategies in HIV prevention trials. I collaborated with the HPTN team to enhance study adherence.

Data Management Communication Skills Collaboration Problem Solving Quality Assurance Clinical Research Training

PMTCT Educator and Coordinator

Project HOPE Malawi

Jan 2001 - Jun 2002 (1 year 5 months)

Monitored and evaluated maternal health programs, providing coaching and support to community teams. I managed data entry and reporting processes to enhance program operations.