Study Coordinator
4 weeks ago
**Job Advert Summary**:
**Minimum Requirements**:
**Minimum Requirements**:
- Honours/Masters degree in relevant field.
- At least 3-4 years' experience in a similar role within a research environment
- Demonstrated computer literacy (including Excel, Word, Outlook & Adobe).
- Minimum 3-4 years’ experience in data entry, able to capture data efficiently and accurately;
- Minimum 3-4 years’ experience in conducting QC / QA of research data;
- Minimum 3-4 years’ experience in the research environment identifying data collection errors and facilitating corrections according to good clinical practice guidelines;
- Able to understand and implement the data processing procedures for multiple project as per the approved project protocol;
- Able to engage and work closely within the component, and with project personnel to ensure the highest standards of data quality and adherence to the study protocol;
- Willing and able to be based (consecutive nights-outs) in various parts of KwaZulu-Natal province;
- Willingness to work after hours and over weekends and in rural communities;
- Ability to speak both isiZulu and English.
**Preference will be given to applicants with**:
- Masters degree in relevant field;
- Clinical research and trial(s) experience;
- Commitment to working as part of a multi-disciplinary research team;
- Ability to work to strict deadlines;
- Ability to problem solve and to be well organised;
- Accuracy and attention to detail;
- Good knowledge of HIV/AIDS
- Ability to actively contribute to team performance and work independently;
- GCP certification;
- REDCap experience;
- Drivers license;
- Technologically savvy.
**Duties and Responsibilities**:
**Key responsibilities**:
- Co-ordination of Research Activities
- Engaging with stakeholders and gatekeepers
- Project implementation and ongoing support and monitoring
- Development of and ensuring compliance with SOPs
- Ensuring timely accrual of participants in the study for allocated teams
- Ensure security of study documentation
- Compiling of reports on request of study manager and/or study director
- Organize training of team
- Coordinate and lead team meetings
- Prepare and send weekly report to study manager and/or study director
- Vehicle fleet management for assigned team
- Supervision and Training
- Supervision and training of allocated teams
- Monitoring and Evaluation
- Assure study integrity, ethical conduct of research and timely reporting of results
- Oversee the logístical and scheduling issues associated with the study, including meetings with site personnel, and personnel issues
- Conduct study monitoring site visits
- Support the study coordinator in all projects related activities
- Primary point of contact for assigned projects, leading data processing and quality checking per the project protocol;
- Supervise issue and receipt of study documentation;
- Data transmission and data downloads from data collection and processing tools;
- Ensuring timely data entry within agreed benchmarks for completion and data quality;
- Filing and document management and archival for assigned projects;
- Identifying and flagging missing/inconsistent data for resolution;
- Query resolution and reporting;
- Quarterly data audits;
- Tracking and providing reports of QC metrics to study manager and study director.
- Support the Project Manager to ensure research protocols are implemented with strict adherence to the protocol, SOPs and CRF completion requirement in accordance with GCP;
- Ensure that tasks delegated to Data collectors are done and monitor their progress;
- Keep total enrolment/completion numbers updated and available for reports;
- Conduct training and refresher training related to improvement of data collection;
- Assist in preparing participant files including printing of paper forms (CRFs), and assembling files with dividers, labels and appropriate forms and data collection tools;
- Perform daily quality control checks of CRFs, surveys and other data collection tools;
- 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;
- Ensure that daily entry of data from participant files/forms into the REDCap database is accurately done;
- Assist with data cleaning and analysis as requested;
- 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 Collectors;
- Ensure accuracy of data entered in data abstraction forms, locator forms, enrolment log, blood specimen register etc;
- Ensure completeness of files
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