Study Coordinator

3 days ago

Johannesburg, South Africa AJ Personnel Full time

**Main purpose of the job**:

- To administer, maintain and coordinate the logístical aspects of clinical trials according to good clinical practice, the study protocol, and the standard operating procedures and to act as a pivotal point of contact for the clinical trial team and the donors

**Location**:

- **Shandukani Research Centre, Wits RHI, Hillbrow**

**Key performance areas**:

- Assist and oversee participant recruitment, screening, and enrolment of eligible participants according to protocol requirements
- Maintain screening and enrolment logs on SharePoint/One drive
- Maintain Screening Failure documentation
- Inform participants about the study
- Liaise with sponsors to ensure CRFs and laboratory kits are prepared
- Provide background information to participants prior to informed consent being signed
- Book and/or perform study-specific pre-screening procedures and perform eligibility enrolment checklist as required
- Conduct Informed consent process according to GCP, study protocol, and site SOPs
- Oversee and support retention of participants (scheduling of visits, contact of participants, follow up of missed visits)
- Conduct pre and post-HIV Counselling (if needed)
- Do direct data entry if required and specified as per delegation log
- Adherence to all protocols
- Manage scheduled and unscheduled participant visits and appointments in accordance with the study protocol and record it in the research calendar and visit log
- Preparation of participant study (scheduled and unscheduled) visits
- Update and maintain participant files
- Perform participant vitals (as and when required)
- Assist with performing electrocardiograms, collect sputum and urine
- Assist with drawing of blood samples in infants and perform phlebotomy in older children and adults
- Assist with the collection, processing, storage, and shipment of specimens
- Involved in reporting any adverse events within required time frames
- Complete relevant questionnaires and assessments
- Provide appropriate health education and counseling where necessary
- CRF data entry and direct data entry
- Ensure that labs are printed, converted, graded, and reviewed by an investigator prior to CRF completion, according to SOPs; and complete DCFs as required
- Maintain an inventory of laboratory samples
- Liaise with protocol team and various stakeholders, as required
- Attend conference calls and training, as required
- Ensure the Emergency trolley is appropriately stocked
- Take responsibility for the Emergency research Cell phone (and related duties) during allocated time periods
- Attending research and clinical team meetings and updating the research meeting minutes for own studies on a weekly basis within the required timeframes
- Review initial Informed consent and translations
- Perform quality control procedures on source docs, CRFs, and other study documents as well as direct data entered on the database and perform real-time QC
- Assist proactively with resolving queries from QC, DMC/EDC/eData, QA and monitors
- Maintaining QC reports
- Prepare files for monitoring visits, audits, inspections and meet with relevant external stakeholders
- Involved in compiling and reporting of Notes to File, Protocol Deviations as well as corrective and preventative actions
- Ensure that preventative actions set out in CAPA documents are strictly followed and implemented
- Supervise and manage the duties of subordinates
- Perform and facilitate performance development and assessment through individual coaching and other support mechanisms
- Timekeeping and leave proactively managed
- Take ownership and accountability for tasks and demonstrates effective self-management
- Manage calls, SMS, and data usage for the Research Cell phone during the times it is allocated to you
- 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 for driving own career development in attending training and development sessions and relevant meetings
- Prepare for, arrange and conduct protocol training as required for new and old staff (e.g new protocols, protocol refreshers)

**Required minimum education and training**:

- **Relevant Nursing Diploma or equivalent (3 years)**

**Required minimum work experience**:

- **Minimum 2-4 years experience in clinical trials environment**

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

- Certification in good clinical practice (GCP) and HIV management
- Experience in phlebotomy and project management
- Working experience in a medical research environment
- Thorough with good attention to detail
- Ordered and systematic in approach to tasks, with strict compliance to protocols
- Exceptional organizational and administrative skills with working knowledge of Microsoft Office
- Able to exercise discretion and independent decision-making
- Able to prioritize own

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