Job Description

The CCBR is looking for a suitably qualified persons to take on the responsibilities of Study Coordinator for research projects implemented at the Sweetwaters office. The successful candidates will be assigned to coordinate multi-year projects conducting research in the community setting. There is one (1) position offered on a 13 month contract.
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 yearsxe2x80x99 experience in data entry, able to capture data efficiently and accurately;

• Minimum 3-4 yearsxe2x80x99 experience in conducting QC / QA of research data;

• Minimum 3-4 yearsxe2x80x99 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 & 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 logistical 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 after participant completes study enrolment or drops out during enrolment;

• Recommend and monitor corrective and preventive actions;

• Ensure files are not placed in locations where they can be damaged by rain/floods, theft etc;

• Ensure that all files are returned to locked file cabinets at the end of each day;

• Ensure all surveys, forms and lab results are placed in correct tabs and secured in the file folders;

• Ensure patients files are never removed from the clinic for any reason;

• Assist with data cleaning and analysis as requested.

• Willing and able to be based (consecutive nights-outs) in various parts of KwaZulu-Natal province;

• Problem solving Skills

• Planning and coordinating skills

• Written & verbal Communication skills

HSRC