Clinical Trial Assistant - Port Elizabeth 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