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
Please send your CV to ****** & ******
Job Type: Full-time
Application Deadline: 2024/09/13
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