To coordinate Oncology studies and manage data.
Coordinate all clinical study activities between International Sponsors, Doctors, Nursing staff, outside vendors (Radiologists, Cardiologists, Pathologists, or others according to protocol) and the patient. Collect reports and manage all clinical data to the sponsor company.
Interpersonal factor
- As a professional, all services delivered need to be in line with the Cancercare values of CARE. Each task needs to be consistently executed whilst at all times displaying a positive influence on all stakeholders and within the general working environment. It is expected from the employee to deliver all tasks reflecting a willingness to operate outside the scope of the job description as per operational requirements.
- To display the company values: C - Compassion, A - Accountability, R - Respect, E - Ethics (CARE).
Preparation for study
- Meeting with sponsor delegate to discuss all aspects of the site and requirements to run the study and tour of facility.
- Required to travel for investigator meetings. Ensuring you have a valid passport.
- 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.
- Site must at all times meet all the required international standards to run an oncology study.
- 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 database locks, etc.
- To ensure that Drug Safety Department is alerted to Serious Adverse Events. This ensures that other participating sites are alerted.
Clinical Trial Coordination and management
- Ensuring that the latest versions of protocols and ICFs are used.
- Shipping or uploading of radiology imaging, ECG’s, etc. to the central reviewers and biological samples to central laboratories.
- 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.
- Send weekly emails to Financial administrator in order to complete orders of work done.
- Prepare billing instructions.
- 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 with 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 the financial impact of work done.
Presentations and attending of academic meetings
- Giving presentations both for the clinical research unit and practice on relevant clinical study topics.
- To educate and give training on clinical study topics to ensure better understanding of the importance of clinical research.
Patient management
- Collecting and reviewing all patient medical history for reviewing by investigator before patient is enrolled into screening.
- Preparing patient files for visits according to protocol-specific requirements for the visits.
- Arrange radiology, cardiology, or other special investigations on the correct time points as specified by the study protocol.
- 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 regarding AE’s, etc.
- Collecting, centrifuging (spinning-off), and handling (packaging) of blood samples in preparation for lab analysis.
- Explaining and having patients complete quality of life questionnaires at the correct time points in the correct manner.
- To ensure patients’ eligibility before enrollment.
- Ensuring that new amendments relating to protocols and ICFs are used. This is important for patient safety and protocol requirements.
- To ensure that all radiology, 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.
Required minimum education:
Registered Nurse (Degree or diploma in Nursing).
SANC registered.
Current passport.
Required minimum experience and other information:
2 years Nursing and Clinical research experience.
Oncology experience will be advantageous.
Computer literacy (MS Word, Excel, Outlook).
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