To act as the primary contact of the project team with study site personnel and to provide the Investigators with logistical and practical advice, training, assistance or support, ensuring the clinical trial is conducted in accordance with international Regulatory and Ethical guidelines for Good Clinical Practice. To assist and support the Project Team and the Project Manager, the Senior CRAs and the CRA I with the day-to-day running of international clinical studies. To interact with the Sponsor if required in the absence of the SCRA or Project Manager.
Assist the Project Manager and Senior CRAs with the day-to-day running of international clinical studies. Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation. Track and supervise collection of ongoing study data for purpose of regular project status reporting. Review study related documentation for compliance with SOPs and ICH-GCP & FDA Guidelines, particularly Regulatory / Ethics Committee review and approval, CVs, drug accountability, translations and SAE reports. Alert Medical Adviser / Director and Project Manager immediately on receipt of SAE report from study site, prior to forwarding to the Sponsor. Provide secondary in-house review of CRFs (if required) and some quality control of in-house files. When additional resource is required and authorised by line manager, assist local CRAs during periodic assisted site visits, or with local office duties e.g. CRF secondary monitoring or DCF generation, prior to transmission to the Sponsor. Follow up Sponsor's requests for clarifications; supplementary information; distribution of newsletters and review approval of protocol amendments; financial disclosures (FDA), Clinical Investigator Brochure revisions; translations, etc. track all activities and versions in-house. Assist the SCRAs/Project Manager with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission. Obtain key GCP documents prior to Site Initiation for appropriate filing and distribution. Maintain updated study Site and In-house files for the duration of the study. Identify the documentation required for review by Regulatory Authorities and Ethical Committees. Prepare Regulatory and Ethics Committee submissions. Ensure written approvals are obtained and distributed appropriately prior to Site Initiation. Organise processes for interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, liaison with POI accountant, logging trial expenditure, receipts, invoices and income. Liaise with the CRA I and II and hospital management, legal advisors regarding the Investigator Contract/Hospital Contract and if appropriate track, generate or amend such agreements according to local laws and regulations. Track receipt of Investigator Contract (and any additionally required site contracts, e.g. Hospital, Laboratory. Pharmacy or Radiologist contract) ensure the CVs of all key site staff are obtained and signed prior to Site Initiation. In collaboration with Clinical Trial Associates maintain local office country and centre files and securely store all other trial materials under appropriate conditions. File a hard copy of all trial documentation in the relevant Country or Centre files as per POI SOPs and CTMS. Regularly review the status of key documentation in the Master / Country files, in compliance with SOPs and to facilitate satisfactory audit or inspections. Produce and maintain computerised records of study progress; receipt/transfer of documentation and/or site visit schedules
Qualifications & Skills Required
Relevant life science degree / medical / nursing background Adequate experience at CRA grade I and II level Read and understood Pharm-Olam SOPs Good eye for detail Good knowledge of the Clinical Trial process Experience in conducting allocated tasks Read and understand Pharm-Olam SOPs Excellent communication skills Excellent English both written and verbal skills Ability to develop, organise and manage new skills and tasks Ability to travel as required Strong organisational skills Ability to prioritise