Clinical Trial Assistant - RondeboschFull job descriptionTo assist in invoicing and receiving prompt payment of all clinical studies. Regulatory and general administration of clinical trials.To assist in financial invoicingAdministration of all regulatory application documents for clinical trialsGeneral administration for clinical trialsInterpersonal FactorAs 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 feesNegotiations of the Clinical Trial Agreement and budget per study with sponsor companies, in discussion with rest of study team and unit business managerSubmit CTA and budget to compliance officer and Unit Business Manager for review and approvalCo-ordinate final signatures by all relevant parties to ensure CTA and budget are valid legal documentsSet up of all Pastel customer accounts for a new studySet up of inventory items as per financial agreement for a new studyDaily input of visits as ordersConfirm with Clinical Research Associates during monitoring visits that captured orders can be invoiced to sponsor companyMonthly invoicing of all visits monitoredLiaise with third parties regarding missing/incorrect information on their tax invoice/statement eg. VAT number, Company nameSend 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 receivedCapturing of chemotherapy fees on a daily basis after comparing cover sheet with attached E AUTH billing sheetsEnsure a profitable financial income for the research unit from the clinical study budgetTo ensure prompt and correct payments to Research Unit in keeping with yearly financial forecastAccurate & timeous capturing of visits for submission to sponsor companies to ensure prompt paymentTo provide the correct invoices to Sponsor companies after monitoring visitAccurate & timeous capturing of fees for submission to medical aids to ensure prompt paymentCapturing of payments from outside vendor companies and debt collectionCapturing of sponsor companies’ payments from remittance advisesTrack all payments receivedAssisting Head Office in reconciliation of all financial affairsFollow up on all outstanding paymentsAccurate & timeous capturing of payments to decrease debtor’s days.Accurate & timeous depositing of payments to increase cash flowTo decrease debtors’ daysWeekly and monthly proceduresEmail summary listings of tax invoices, credit and debit notes to Head OfficeExport, save, update tax invoices, credit, debit notesExport and save inventory itemsSpreadsheet of month-end figures for Clinical Research PhysicianEmail age analysis to Head OfficeBackup of dataTo ensure accurate, timeous & updated customer accounts to keep them informedTo ensure safekeeping of dataTo ensure paymentAdministration of all regulatory application documents for clinical trialsPreparation of all regulatory application documents for clinical trials for all site staffFollow-up of all regulatory documents sent to site staff in order to minimize time of preparation of regulatory documentsSubmission of all regulatory documents to Sponsor companies in a timely mannerCorrespondence with all councils e.g. HPCSA,MPSCorrespondence with Sponsor companies and handling of queries regarding regulatory documentsOrganizing and tracking of Good Clinical Practice training and certificatesEnsuring a well-organized and speedy submission of regulatory documents to Sponsor companiesProactive planning of GCP coursesHaving all necessary regulatory documents available for regulatory submissionsUnblinded site staff dutiesUnblinded Pharmacist on various studiesReceipt and acknowledgement of IP on IVRS systemDrug allocation on CRF and liaising with PharmacistsDrug reconciliation & accountabilityUpkeep of Pharmacy Binder FilesLiaise with Unblind Monitors on monitoring visits regarding current and used IPData capturing on E -CRF’sEnsure 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 FilesGeneral administration for clinical researchResponsible for filing of all confidentiality agreements, study feasibilities, study protocols and clinical trial agreements as applicableKeeping of unit statisticsOrdering of all stationary for the unitTo 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 waybillsTo 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 trackingMaking 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’sEmail queries from service providers and CRA’Filing of all original site Clinical Trial AgreementsFiling of chemotherapy billing and hospital visit sheetsFiling of remittance advisesElectronic filing of third party statements receivedElectronic back-up system of all essential documentsReadily available statistics on all patient referralsEnsure that all parcels are handed correctly and send as per study specificationsEnsure smooth coordination of all study specific visits and proceduresTo improve professional and efficient client services and customer satisfactionEnsure that all important documents are filed systemically as well as electronicallyEasy access to information when requiredEnsure accurate capturing Required minimum education:Registered and/or Enrolled nurseSANC registrationCurrent passportRequired minimum experience:2 years Clinical research experienceComputer literacy (MS Word, Excel, outlook
