Clinical Trial Assistant

To assist in invoicing and receiving prompt payment of all clinical studies. Regulatory and general administration of clinical trials.
- To assist in financial invoicing
- 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**
- Export, save, update tax invoices, credit, debit notes
- Export and save inventory items
- Spreadsheet of month-end figures for Clinical Research Physician
- Backup of data
- To ensure accurate, timeous & updated customer accounts to keep them informed
- To ensure safekeeping of data
- To ensure payment
- 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 vendor