Data Quality Control Officer

**FRESH: Females Rising through Education Support and Health** *Data Quality Control Officer * **PURPOSE** The Health Systems Trust (HST) wishes to appoint a **Data Quality Control Officer (QCO)** for the 'Females Rising through Education Support and Health' (FRESH) programme based in **Umlazi, KwaZulu-Natal.** The FRESH programme conducts basic science research, combined with a skills development/empowerment programme for young female study participants. FRESH research is primarily focused on HIV and other women's health issues. The FRESH skills development programme focuses on job readiness, women's issues, and empowerment modules. This is a 12-month fixed-term contract position, renewable at the discretion of the programme, based on funding, performance and need. **KEY RESPONSIBILITIES** The QCO is responsible for the overall data quality assurance (QA) to ensure that data are recorded, entered and uploaded in accordance with the protocol and Good Clinical Practices (GCP). The QCO will help to identify data errors, recommend and monitor corrective and preventive actions and help monitors to ensure the highest data quality. The QCO will help to ensure compliance with medical data privacy, security, and GCP regulations. The QCO will also follow GCP guidelines to ensure the ethical and scientific quality standards for the design, conduct, recording, and reporting of IRB-approved clinical studies and trials that involve research participants. Additionally, the QCO may assist with creating sampling/visit calendars, and monitor enrolment, adherence to visit schedules, default, and disenrollment. **Overview** - Support the Clinical Director, Programme Manager, Study Co-ordinator, and PIs to ensure research protocols are implemented with strict adherence to SOPs and CRF completion in accordance with GCP. - Delegate tasks to data capturers and monitor progress. - Keep total enrolment/completion numbers updated and available for reports. * Screening and Enrolment* - Assist with screening of participants as needed; have time available to explain study objectives, screening and enrolment criteria to potential and new study participants. - Conduct or delegate staff to deliver V1 presentations as necessary to ensure participants understand the FRESH Study and are ready to be consented by FRESH staff. * Files and Source Documents* - Assist in preparing participant files including printing of paper forms (CRFs), and assembling files with dividers, labels and appropriate forms and data collection tools. - Assist with printing of accurate stickers on a regular basis. **Data Entry and QC** - Perform daily quality control checks of CRFs, prior to data entry. Ensure forms are filled correctly and there are no blanks or missing information. - If data is missing on the forms, immediately notify the individual who filled the form and have them correct or fill in the missing data on the same day. - Perform daily entry of data from participant files/forms into the REDCap database, including baseline demographics, clinic visit form, three-monthly questionnaire, enrolment and disenrollment data as well as any other participant data. - Perform daily entry of data into logs and excel spreadsheets including enrolment log, attendance register, bloods and mucosal register, disenrollment log, retention data, acute data, post-graduation placements, etc. - Perform data entry for V1 and V2 participants tracking total screened, total eligible, reason not eligible, total did not show for V2 and total started week 1 of twice weekly follow-up. **Data Analysis** - Assist the QCO with data cleaning and analysis as requested. **Lab Results** - Contact HPP and Neuberg-Global, as needed, to verify missing or irregular results; ensure all data and time points are consistent across all sites (FRESH CRS, HPP, Neuberg-Global). - Access Neuberg-Global online database to print missing results or lab forms as needed. **Data Management** - Ensure proper version control is maintained for all CRFs and data collection tools. - Review and verify all source data to ensure the completeness, accuracy and consistency. - Assist with development and implementation of a monitoring and evaluation (M&E) system to ensure accurate and efficient entry of data into the REDCap database, including spot-check and "double entry" of data entered by the Data Capturer. - Ensure accuracy of data entered in enrolment log, attendance register, bloods and mucosal register, disenrollment log, retention data, acute data, placements after FRESH, etc. - Ensure completeness of files after participant completes study enrolment or drops out during enrolment. Store completed files in boxes and ensure they are shipped to a storage facility on a regular basis. - Upload data to the CRO and assist with resolving discrepancies. - Recommend and monitor corrective and preventive actions. - Assist with data cleaning and analysis as requested. **File Security** - Create and print correct P