Latest Roles at Cancercare SA

Description

Invoicing and receiving prompt payment of all clinical studies. Regulatory and general administration of clinical trials.

• Financial invoicing
• Administration of all regulatory application documents for clinical trials
• General administration for clinical trials

Interpersonal Factor

• As a professional all services delivered needs 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 the tasks reflecting a willingness to operate outside the scope of the job description as per operational requirements. The factors below cannot therefore be reviewed and assessed in isolation.
• To display the company values: C - Compassion, A - Accountability, R - Respect, E - Ethics (CARE)

Invoicing of sponsor companies and capturing of fees

• Negotiations of the Clinical Trial Agreement and budget per study with sponsor companies, in discussion with rest of study team and unit business manager
• Submit CTA and budget to compliance officer and Unit Business Manager for review and approval
• Co-ordinate final signatures by all relevant parties to ensure CTA and budget are valid legal documents
• Set up of all Pastel customer accounts for a new study
• Set up of inventory items as per financial agreement for a new study
• Daily input of visits as orders
• Confirm with Clinical Research Associates during monitoring visits that captured orders can be invoiced to sponsor company
• Monthly invoicing of all visits monitored
• Liaise with third parties regarding missing/incorrect information on their tax invoice/statement eg. VAT number, Company name
• Send third party statements to Head Office for payment (Ensure it has to be signed by Coordinator, Doctor and Unit Business Manager)
• Invoice sponsor company for third party statements received
• Capturing of chemotherapy fees on a daily basis after comparing cover sheet with attached E AUTH billing sheets
• Ensure a profitable financial income for the research unit from the clinical study budget
• To ensure prompt and correct payments to Research Unit in keeping with yearly financial forecast
• Accurate & timeous capturing of visits for submission to sponsor companies to ensure prompt payment
• To provide the correct invoices to Sponsor companies after monitoring visit
• Accurate & timeous capturing of fees for submission to medical aids to ensure prompt payment

Capturing of payments from outside vendor companies and debt collection

• Capturing of sponsor companies’ payments from remittance advises
• Track all payments received
• Assisting Head Office in reconciliation of all financial affairs
• Follow up on all outstanding payments
• Accurate & timeous capturing of payments to decrease debtor’s days.
• Accurate & timeous depositing of payments to increase cash flow
• To decrease debtors’ days

Weekly and monthly procedures

• Email summary listings of tax invoices, credit and debit notes to Head Office
• Export, save, update tax invoices, credit, debit notes
• Export and save inventory items
• Spreadsheet of month-end figures for Clinical Research Physician
• Email age analysis to Head Office
• Backup of data
• To ensure accurate, timeous & updated customer accounts to keep them informed
• To ensure safekeeping of data
• To ensure payment

Administration of all regulatory application documents for clinical trials

• Preparation of all regulatory application documents for clinical trials for all site staff
• Follow-up of all regulatory documents sent to site staff in order to minimize time of preparation of regulatory documents
• Submission of all regulatory documents to Sponsor companies in a timely manner
• Correspondence with all councils e.g. HPCSA,MPS
• Correspondence with Sponsor companies and handling of queries regarding regulatory documents
• Organizing and tracking of Good Clinical Practice training and certificates
• Ensuring a well-organized and speedy submission of regulatory documents to Sponsor companies
• Proactive planning of GCP courses
• Having all necessary regulatory documents available for regulatory submissions

Unblinded site staff duties

• Unblinded Pharmacist on various studies
• Receipt and acknowledgement of IP on IVRS system
• Drug allocation on CRF and liaising with Pharmacists
• Drug reconciliation & accountability
• Upkeep of Pharmacy Binder Files
• Liaise with Unblind Monitors on monitoring visits regarding current and used IP
• Data capturing on E -CRF’s
• Ensure that participants are not privy to certain information related to the study to avoid the results being tainted.  
• Ensure that IP in IVRS system has been acknowledged.
• Ensure up to date and correct information on CFR and Pharmacy Binder Files

General administration for clinical research

• Responsible for filing of all confidentiality agreements, study feasibilities, study protocols and clinical trial agreements as applicable
• Keeping of unit statistics
• Ordering of all stationary for the unit
• To perform and be available for all Reception activities for the Clinical Research Physician. Duties such as patient bookings, mark patients as arrive, phoning other doctors and/ or vendors.
• Faxing/ emailing letters as applicable.
• Receiving and distributing of all courier parcels.
• Arranging of all courier collections and preparation of waybills
• To help out with general administrative tasks as might be needed from time to time e.g. filing of source documents in patient files, medical aid authorizations tracking
• Making appointments for all study specific procedures including visits to investigators, physician extenders, clinical research coordinators, and outside vendors e.g. radiologists, cardiologists.
• Telephonic queries from service providers and CRA’s
• Email queries from service providers and CRA’
• Filing of all original site Clinical Trial Agreements
• Filing of chemotherapy billing and hospital visit sheets
• Filing of remittance advises
• Electronic filing of third party statements received
• Electronic back-up system of all essential documents
• Readily available statistics on all patient referrals
• Ensure that all parcels are handed correctly and send as per study specifications
• Ensure smooth coordination of all study specific visits and procedures
• To improve professional and efficient client services and customer satisfaction
• Ensure that all important documents are filed systemically as well as electronically
• Easy access to information when required
• Ensure accurate capturing

Requirements

Required minimum education:

• Grade 12, Good Clinical Practice certificate and computer literate in Pastel

Required minimum experience:

• Finance experience in a medical environment
• Clinical research experience advantageous

Required minimum work-related experience:

• Clinical research experience advantageous

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Description

To provide holistic patient centered nursing care to oncology patients undergoing chemotherapy and other modalities of treatment in accordance to Cancercare’s standards, policies and procedures.

• To assess, develop, implement ,evaluate and record patient care.
• To work with members of inter professional team to ensure quality of care for patients are maintained and that the patients’ needs are met.
• To conform to the Health and Safety regulations whilst dealing with cytotoxic chemotherapies ensuring a safe working environment.
• To provide evidence based clinical advice, education and support to patients and relatives.
• To comply with relevant policies, procedures, guidelines, protocols and codes of conduct of Cancercare and the bodies that accredit our company and profession.

Interpersonal factor

• As per professional all services delivered needs 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 the tasks reflecting a willingness to operate outside the scope of the job description as per operational requirements. The factors below cannot therefore be reviewed and assessed in isolation.
• To display the company values: C – Compassion, A – Accountability, R – Respect, E – Ethics (CARE)

Administration of chemotherapy and other oncology treatments

• Acts in a supervisory capacity over Chemotherapy Extenders/Physician Extenders.
• Provide and supervise the delivery of evidence based  holistic nursing care, using the nursing process to assess, plan, implement and record the plan of care for patients undergoing chemotherapy .
• Correctly interpreting and managing blood results, in consultation with a doctor
• Monitor, interpret and record patient’s vital data, reporting abnormalities to the doctor.
• Establish and keep record of patients allergies.
• Provide patients with relevant written information regarding their treatment and ensure patient has a signed informed consent.
• Demonstrate knowledge and competency in intravenous access, the management of intravenous catheters, including the management of extravasation.
• Program the infusion pumps as applicable to patient specifics and instruct patients on the usage of pumps for home care as applicable.
• Administer chemotherapy and other oncology treatment including anti-emetics and supportive therapy according to protocol.
• Verify chemotherapy drugs as per protocol and query the rationale behind the decision  of chemotherapy regimens that varies from standard regimens with the treating oncologist.  
• Educate patient on the effects and side effects of chemotherapy and other oncology treatments.
• Prevent, identify, report and record adverse reactions of chemotherapy and other oncology treatments to the doctor.
• Provide emotional support for patient and family during treatment and refer to Oncology Social Worker as necessary.
• Co-ordinate follow up of treatment plans by scheduling patients correctly.
• Provide applicable discharge instructions and health education to patients and significant others including an emergency contact number of a health care professional who is available 24hours.
• Collaborate with members of the inter-professional team and service providers to ensure optimal patient.
• Recordstatistical data
• To ensure scientific nursing practice within the legal framework of nursing.
• To ensure that accurate documentation of patient care within legal framework of nursing
• To promptly react and report any abnormal blood results
• To identify and assess patient's condition and readiness to receive chemotherapy
• Informed patients
• To maintain  aseptic principles as applicable and prevent the risk of vesicants and irritants
• Daily scheduling of all patients
• To accurately administer the correct dose of chemotherapy
• To accurately administer the correct dose of chemotherapy to the correct patient
• Administer safe treatment within the company policies
• To ensure that the emotional needs and health education needs of the patient is met.
• To ensure continued care and correct scheduling of all patients
• To ensure updated communication of patient’s information to all healthcare providers involved in the patients care.
• Updated monthly stats

Safety awareness and risk management

• Practice the principle of infection prevention and control and adhere to all standard precautions inclusive of PPE’s as per institutional policy.
• Adhere to the Sharps protocol.
• Maintain a therapeutic, clean and safe working environment in accordance with the Occupational Health and Safety Act.
• Keep a record of chemotherapy adverse events.
• Ensure effective risk prevention and report and act upon potential/actual risk identified
• Apply Cardio Pulmonary Resuscitation as necessary.
• Correctly use clean and store equipment as per institutional policy.
• Report equipment needing repair or replacement to the registered nurse/UBM.
• Adhere to the Medical  Waste management principles inclusive of cytotoxic waste
• Check emergency trolley/oxygen cylinders
• Prevent and educate patients on the risk of falling as applicable
• To minimize the risk of infections.
• To prevent sharp injuries.
• Compliance and adherence to legislation and policies
• To ensure staff and patient safety
• Ensure appropriate resources present to avoid treatment delay.

Quality assurance

• Actively support and participate in ongoing Continuous Quality Improvement activities.
• Adhere to patient satisfaction program as per institutional program and protocol.
• Refer patient complaints to the chemo supervisor/UBM/Doctor.
• To ensure quality care rendered.

Billings

• Correct capturing of patient billings daily.
• Ordering of Consumables as necessary
• Confirm correct medical aid authorization of treatment.
• To ensure correct billing of patients.

Continued Professional Development

• Keep up to date with Cancer care’s policies and procedures.
• Participate in ongoing in  personal and professional development.
• Maintain personal competence in BLS.
• Maintain personal competence in GCP for trials where applicable.
• Assist with the coaching of subordinates and junior staff within the unit
• Participate in unit academics.
• To ensure and improve knowledge, skills and attitudes relevant to oncology practice.
• To practice safely and ethically.

Requirements

Required minimum education:

• General Nursing Diploma Registered

Required minimum experience:

•  Current clinical experience in Oncology nursing care of at least 3years.

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Description

To coordinate Oncology studies and manage data

Coordinate all clinical study activities between International Sponsors, Doctors, Nursing staff, outside vendors (Radiologists, Cardiologists, Pathologists or other 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 needs 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. The factors below cannot therefore be reviewed in isolation.
• 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 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.
• 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 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

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 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.
• 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 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 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.

Requirements

Required minimum education:

• Registered Nurse (Degree or diploma in Nursing)
• SANC registered
• Current passport 

Required minimum experience and other information:

• 2 year Nursing and Clinical research experience
• Oncology experience will be advantageous
• Computer literacy (MS Word, Excel, outlook)