Clinical Trials Associate
POI seeks Clinical Trials Associates to assist Senior CTAs, CRA, Senior CRAs and Project Managers with the day-to-day running of clinical studies. This is an in-house, full-time position, based at POI-Romania headquarters in Bucharest.
Key Responsibilities & Critical Objectives
- Manage all aspects of trial administration for assigned studies.
- Maintain project study files to the high standard required to fulfil the requirements of a sponsor audit.
- Set up investigator site files according to POI SOPs.
- To prepare and distribute minutes for Sponsors and Project Teams.
- Assist with the preparation of Investigator Site Files, Investigator Manuals & Training Manuals.
- Ensure that all essential trial documentation is prepared and despatched as specified by the sponsor company.
- Track all critical documentation received and sent.
- Responsible for archiving study files.
- Assist with preparation of overheads for presentation by Project Team - including monitors.
- Organise buffet lunches for meetings
- Provide agendas, badges, certificates, register of attendees and any other documents required for meetings
- Assist monitors with planning Investigator and GCP Training Meetings that will be held in their country
- Sponsor/Monitor meetings - organise flights and hotel requirements
- Code all study related expenditure
Education Requirements and Qualifications
- Relevant clinical administration experience
- Appropriate IT skills as required to perform duties, including experience in MS Word and Excel
- Understanding of Pharm-Olam SOPs
- Good written and verbal communication skills
Please send CV and salary requirements to hr-romania@pharm-olam.com
NO PHONE CALLS PLEASE. |