Job offer: Quality Assurance Officer at SolidarMed

VACANCY – QUALITY ASSURANCE OFFICER – VICONEL 2.0

SolidarMed is a leading non-profit organization working to improve the health care of 2.5 million people in Lesotho, Mozambique, Tanzania, Zambia and Zimbabwe. Working with national partners to strengthen health systems and community capacities, we are committed to scientific evidence and policy dialogue both as foundations and objectives of our work.

The Quality Assurance Officer is responsible for ensuring that the VICONEL study and nested/associated studies (such as Ndovu) are conducted according to the study protocols and GCP standards, ensuring correct and timely data collection and documentation at each site, ensuring correct consenting procedures, and facilitating smooth VICONEL operations.

Contract Type

Full time

Place of Assignment

Butha Buthe with frequent travel to MKG and Leribe district

Main Tasks and Responsibilities:

• Ensure that the VICONEL and nested studies are conducted as per study protocols and following GCP standards.
• Maintain complete, accurate and correct documentation of all study procedures at each study site as well as in the SolidarMed office in Butha-Buthe. Oversee management of the study documentation, ensuring timely filing of amendments, regulatory approvals, CVs, certifications and updating of activity delegation logs.
• Verify that signed consent forms for all project components and nested studies are complete, properly stored and accurately documented in the VICONEL database. Ensure clear documentation of participant enrolment in the patient file and bukana.
• Track team members’ GCP certifications and send reminders for timely renewal to ensure continued compliance.
• Ensure proper filing of SOPs, relevant communications, and monitoring visit reports.
• Conduct both onsite and remote data and documentation checks
• Regularly review data on study databases (REDCap and VICONEL database) to identify and resolve inconsistencies, collaborating with the VICONEL Data Team as needed
• Maintain up-to-date documentation for REDCap use within the study
• For nested studies with defined windows for clinical action, proactively work with study sites to prevent missed visits or incomplete data; notably, ensure that laboratory assessments are conducted within the window to maintain study timelines
• Address queries from the VICONEL Data Team, following up directly at the study sites where necessary to resolve issues
• Prepare the study sites for monitoring visits, ensuring that documentation and procedures are up-to-date. Address any shortcomings identified during monitoring without delay.
• Oversee the safe and timely transport of study samples, working under the guidance of the VICONEL project manager
• Communicate proactively and work effectively with the VICONEL Management team, VICONEL Clinical Unit, VICONEL Data Unit and other SolidarMed staff as well as study site teams
• Assist with any additional tasks required for the successful implementation of the studies as directed by the VICONEL Management Team

Qualifications Essential

• Bachelor’s degree in a relevant field (e.g. Life sciences, Public Health, statistics) with 3 years minimum experience in clinical research or quality assurance roles within clinical or research settings.

Skills, Required Experience and Competencies:

• Strong understanding of Good Clinical Practice (GCP) and regulatory compliance.
• Proficient in managing and maintaining clinical study documentation.
• Ability to conduct thorough data quality checks and resolve data inconsistencies.
• Excellent organizational skills and the ability to manage multiple tasks.
• Strong communication skills and the ability to work effectively with diverse teams.
• Proficiency in database management tools, preferably REDCap.
• Ability to write clear and concise reports, , work under pressure, and promptly assess and report relevant findings and challengesPositive overview in a complex working environment, good interpersonal skills, reliability, punctuality, and self-motivation.

Added advantage.

• -Experience working in a research setting OR with an NGO conducting monitoring visits and audits .
• Advanced Qualifications: Master’s degree in Public Health, Epidemiology or related field.
• Specialized training in Quality Assurance/Quality Control.

Interested candidates should send applications via email to: [email protected] before close of business 30th January 2025. Subject line: Quality Assurance Officer

Applications must include:

• A cover letter outlining your motivation and how you meet the requirements.
• Detailed Curriculum Vitae indicating relevant work experience and contact details of 3 professional referees.
• Certified copies of your latest and /or most relevant qualifications
• 1 reference letter from your previous HR.

NB:

ALL applications must be submitted via email – NO HARD COPY/in person application submissions will be accepted.

Only short-listed candidates will be contacted.