Clinical Trial Coordinator

**Coordinate** all clinical study activities between International Sponsors, Doctors, Nursing staff, and the patient. Collect reports and manage all **clinical data** to the sponsor company. **One year experience in clinical trials is a requirement**

**Preparation for study**
- Meet with sponsor delegates to discuss all aspects of the site and requirements to run the study
- Organize with Principal and sub-investigators for protocol overview and site initiation meeting. Review of study files with the sponsor delegate.
- Drawing up and designing templates for the source documents used by the investigators according to specific protocol requirements.
- Ensuring coordinator is extensively trained on the study protocol.
- To ensure that everything is in place to start recruiting patients for the study
- To ensure that the correct data is collected and all special investigations are done for specific visits according to the study protocol.

**Data collection and reporting, paper and electronic format**
- Intensive online training on the use of electronic CRFs.
- Enter study specific data onto source documents and paper case report forms or electronic case report forms. Data entering and clarifications to be done within the sponsor specified timelines.
- Gather the required data to report SAE’s, complete the necessary SAE forms and send through to Sponsor/ Drug Safety within 24 hours.
- To ensure proper use of eCRFs for clinical data capture
- To ensure that all data is entered and corrected within study specific timelines and ready for Clinical Research Associates to monitor and be ready for data base locks etc.
- To ensure that Drug Safety Department is alerted to Serious Adverse Events. This ensures that other participating sites are alerted.

**Clinical Trial Co-ordination and management**
- Ensuring that the latest versions of protocols and ICFs are used.
- Phone IVRS/IXRS to alert sponsor about, screenings, end of treatment, dose adjustments, dispensing, etc. and to randomize patients to treatment arms.
- Filing regulatory and other essential documents in the investigator site files according to sponsor guidelines as well as those of GCP
- Responsible for electronic parallel system filing of all confidentiality agreements, study feasibilities and study protocols
- Preparing and reviewing all clinical source data (patient files, regulatory documents) for international or local (MCC, ethics committee) audits
- Regularly do stock check of blood kits, dipsticks for expiry dates and additional kits needed.
- Also check stock of blood pressure machines, electronic diaries or other trial specific apparatus.
- Ensure valid calibration certificates for all medical devices needed
- Have good communication to the study team and knowing who to contact when necessary.
- Ensuring that new amendments relating to protocols and ICFs are used. This is important for patient safety and protocol requirements.
- To ensure that IVRS/IXRS calls are made timeously according to sponsor requirements.
- To ensure that these files are up to date and complete in the case of clinical audits.
- Reducing possible audit findings. To adhere to GCP. Ensuring the integrity, reliability and quality of study data from our study site.
- Ensuring up to date information regarding financial impact of work done

**Patient management**
- Collecting and review of all patient medical history for reviewing by investigator before patient is enrolled into screening
- Preparing patient files for visits according to protocol specific requirement for the visits.
- Perform and document the patient’s vital signs, weight, urinalysis and ECG on scheduled and unscheduled visit days,
- Follow-up on blood results and adverse events
- Take telephone calls from patients re AE’s etc.
- Collecting, centrifuging (spinning-off) and handling (packaging) of blood samples in preparation for lab analysis.
- Explaining and having patient’s complete quality of life questionnaires at the correct time points in the correct manner.
- To ensure patient’s eligibility before enrolment
- Ensuring that new amendments relating to protocols and ICFs are used. This is important for patient safety and protocol requirements.
- To ensure that all cardiology and other special investigations are done at the correct time points according to study protocol.
- To ensure patient safety on treatment days
- Ensuring that quality of life questionnaires are completed correctly and completely according to protocol guidelines.
- Sound interpersonal, communication and language skills
- Ability to work under pressure
- Attention to detail

**Required minimum education**:
Registered Nurse (Degree or diploma in Nursing)

SANC registered

**Required minimum experience and other information**:
2-years in nursing

Computer literacy (MS Word, Excel, outlook)

GCP trained

Application Deadline: 2024/09/13