Research Interns X 4

2 weeks ago

Hillbrow, South Africa AJ Personnel Full time

**Main purpose of the job**:

- To perform day to day of research related activities including but not limited to administration, laboratory activities, data collection, quality control, quality assurance, community recruitment, and retention activities, and ensuring compliance with regulatory and good clinical practice requirements within Research Centre studies at Wits RHI

**Location**:

- **Wits RHI -7 Esselen Street, Hillbrow, Research Centre - Johannesburg**:

- **On the 3rd,4th, and 5th Floor**

**Key performance areas**:

- Assist Medical Technician or Medical Technologist with stock control and monitoring for all studies
- Ensure timeous and logical filling of shipment documents, Lab meeting minutes, and any other lab documents
- Capture, store, and ship samples on LDMS for study-related protocols
- Assist Reg officers/managers and sponsors/monitors before, during, and after monitoring visits
- Support Reg officer/managers to maintain regulatory files and filing systems
- Document regulatory team meetings as and when required
- Ensure staff are compliant with timely GCP training and renewals through active review of trackers and bookings as required
- Review and support the Regulatory Officer/Manager and ensure that the study has all essential regulatory documentation filed and tracked on Excel trackers
- Updating tracking logs for all submissions, approvals
- Promote studies and recruit participants by conducting presentations, radio talks, and distributing brochures at the community
- Address potential participants in accordance with recruitment targets and participant recruitment standard operating procedures (SOP)
- Inform willing participants that participation in the study is voluntary
- Conduct screening interviews with consenting participants to determine eligibility for the study
- Schedule an appointment with eligible participants to attend the further screening at the Wits RHI study clinic
- Record screened participants in the screening register
- Administer study questionnaires
- Contact participants prior to their scheduled visits to remind them of their visits
- Visit home or contact participants telephonically to reschedule visits
- Prepare a list of home visits according to priority and living area
- Address relevant concerns and misconceptions about the study
- Receive queries from participants and address or refer queries accordingly
- Verify transcription and accuracy of data from source documentation to Case Report Forms (CRF)
- Ensure errors on CRFs are corrected, initialed, and dated by the authorized signatory
- Support the timely transmission/data faxing of all Case Report Forms following QC activity
- Ensure completion of corrective action of internal QC reports/error trends identified during QC
- Assist in the completion of corrective action for internal monitoring reviews
- Coordinate staff training (and retraining) where error trends are identified
- QC of all ICFs and other source documents to ensure accuracy and completeness
- Timeous reporting to study PI and study coordinator Regulatory Compliance Officer regarding QC and major issues such as protocol deviations
- Support Regulatory Compliance Officer with periodic quality assurance activities
- Assess staff awareness and compliance to Good Clinical Practice (GCP), Protocol requirements, Standard Operating Procedures (SOPs), and Regulatory Essential Documents per sponsor requirements
- Determine through critical review the accuracy of research records
- Compile QA/QC report/s on findings for the site management team
- Assist in the completion of corrective action for internal monitoring reviews
- Coordinate staff training (and retraining) where error trends are identified
- Ensure 100% QA of ICFs
- Transcribe audio files of focus group discussions and in-depth interviews in accordance with study-specific templates
- Translate local language audio into English using a one-step method
- Review/ quality control completed transcripts naming conventions
- Obtain informed consent from study participants
- Attend relevant external and internal meetings
- Take ownership and accountability for tasks and demonstrate effective self-management
- Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
- Maintain a positive attitude and respond openly to feedback
- Take ownership of driving your own career development by participating in ongoing training and development activities such as workshops, forums, conferences, etc.
- Provide appropriate resolution for tasks or deadlines not met
- Support and drive the organization’s core values

**Required minimum education and training**:

- **Tertiary Degree in a health-related field**

**Required minimum work experience**:

- **Minimum < 1 year of working experience within a clinical research environment**

**Desirable additional education, work experience, and personal abilities**:

- Confidentiality, tact, and discret

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