Data Monitor [South Africa]

 

Duties/Pligte

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  Working closely with the BMRI clinical team, data manager(s) and study statistician(s) to ensure that study procedures and results are accurately reported in the study database (REDCap), in order to facilitate efficient and accurate analysis;
• Monitoring eCRFs for compliance with the specific protocol, Good Clinical Practice (GCP), sponsor and regulatory requirements;
• Monitoring captured data of other study sites for completeness and integrity, if Stellenbosch University is a sponsor;
• Attending meetings and providing feedback and problem resolution on data monitoring issues and monitoring reports;
• Ensuring that data-related SOPs are adhered to and that general/study-specific Data Management Plans are being implemented;
• Implementing designated sections of the BMRI Clinical Data Quality Plan at regular intervals, across all active studies;
• Generating the required Monitoring Reports (including for management reviews);
• Assisting with the generation and review of study-specific Data Quality Management Plans when necessary;
• As part of monitoring reports, providing feedback to data managers and research clinicians with regards to CRFs/eCRFs and source to optimise clarity;
• Ensuring that the integrity and quality standards of the research Unit are maintained;
• Monitoring key fields and algorithms in study-specific databases to ensure adherence to protocols and completeness of data towards study objectives;
• In multi-site studies where Stellenbosch University is the sponsor, helping to monitor key fields for all sites, in collaboration with the data managers;
• Providing feedback on the effectiveness of quality management;
• Assisting with training and development of staff involved in data capturing, data filing, and quality control activities;
• Supervising, monitoring and guiding the data entry and QC Team within the BMRI Clinical Team. (line manager to approximately four staff members);
• Acting as study coordinator for a number of studies, and taking on all study coordinator duties when the need arises;
• Recruiting, scheduling, enrolling, following up and retaining research participants;
• Consenting participants, HIV counselling and testing, and measuring vital signs;
• Collecting research samples as per the study protocol and specific SOPs.

Job Requirements/Pos Vereistes

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  Degree in nursing (B.Cur or equivalent degree or diploma with formal post-diploma training);
• Registration with South African Nursing Council;
• At least five years' experience with clinical research/trials;
• At least three years' experience in quality control in the health research sector;
• Experience with data monitoring or quality assurance in the health research sector;
• Experience of facilitating training and conducting research;
• In-depth knowledge of the REDCap platform (or similar), and its data management functions (including creation of customised reports, query creation, follow-up and resolution);
• Training in good clinical practice (GCP);
• Attention to detail;
• The ability to solve problems independently and effectively;
• A goal-oriented disposition;
• Computer literate;
• Sound interpersonal skills;
• Good written and verbal communication skills;
• Fluency in English;
• The ability to maintain patient confidentiality.

Recommendation/Aanbeveling

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  None.

 

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