Job Description

Job Summary Main purpose of the job:

• To provide critical study conduct support through basic clinical reviews Additional responsibilities include query generation, data reconciliation, reporting, and assisting clinical study team members with the completion and filing of both paper and electronic clinical data, reports, and administrative study documentation

Location:

• NICD,1 Modderfontein Road, Sandringham, Johannesburg or Wits Faculty of Health Science campus

Key performance areas:

• Maintain accurate data entry and perform quality control (QC) checks using tools assigned by the Data or Project Managers
• Conduct basic clinical reviews and support query generation and resolution in alignment with study protocols, SOPs, and the data management plan
• Implement and adhere to the data capturing plan as outlined for the study
• Execute data QC activities within pre-determined timelines to ensure consistency and reliability
• Maintain accurate and comprehensive data coordination files, including all data clarifications and resolutions received
• Ensure all data is accurate, complete, and verifiable against source documents
• Identify and report any protocol deviations or quality issues to the Data or Project Managers
• Assist Data or Project Managers in ensuring only approved versions of study documents are in use
• Verify participant eligibility based on provided data
• Support ad hoc internal investigations conducted by study team members as needed
• Accurately and promptly enter data into databases in compliance with study protocols, SOPs, and directives from the Data or Project Managers
• Maintain and update the quality control (QC) log with all errors identified during data review
• Send reminders to staff to correct errors noted to ensure timely resolution
• Monitor and track the filing of source documents and their inclusion in subject folders to maintain organized and complete records
• Adhere to departmental metrics, maintaining minimal error rates as specified by study protocols, sponsors, or as directed by Data or Project Managers
• Efficiently address data management queries (QC reports) to achieve timely resolution as per sponsor requirements
• Identify actual or potential data-related issues and promptly report them to the Data or Project Coach and train subordinates and team members to ensure the acquisition of knowledge and skills required by the organisation
• Promote harmony, teamwork and sharing of information
• Resolve any transcription discrepancies between CRFs and electronic CRFs to maintain data integrity
• Assist in implementing corrective and preventative actions (CAPA) as needed
• Ensure all hardware and software required for data administration tasks are properly maintained and fully operational
• Adhere to study-specific and site-specific documentation and training requirements
• Perform administrative tasks assigned by the Data or Project Managers within allocated timelines
• Report any faulty hardware or software that requires maintenance or upgrades
• Complete all relevant training, including study SOPs, protocols, protocol amendments, and maintain up-to-date GCP certification

Required minimum education and training

• Matric
• GCP certification

Required minimum work experience

• Minimum 1 years of experience managing data in a research environment
• At least 1 year's experience working with databases, data procedures, and data administration

Desirable additional education, work experience and personal abilities:

• Tertiary qualification in a related field will be advantageous
• Time management skills
• Ability to work with a diverse group of people
• Excellent written and spoken English
• Knowledge of GCP guidelines and clinical trial processes
• Strong organizational skills with attention to detail
• Good self-auditing skills and attention to detail
• Data orientated with good proofreading skills

TO APPLY:

• Only if you meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV
• Please Apply Online and complete your registration via our website to enable and protect you as a candidate, and to accept the new POPIA terms and conditions
• This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL
• However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market
• Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position
• Wits Health Consortium will only respond to shortlisted candidates
• Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful
• Closing date: 23 June 2025
• Note: No CV will be accepted after the closing date

Please note:

• WHC, in accordance with its Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto
• AJ Personnel is only responsible for advertising and the response handling on behalf of their client Wits Health Consortium
• AJ Personnel does not have any salary or other information regarding the position

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