Clinical Research Associate II (outsourcing/FSP model)
- acting as a first contact point for Investigators involved in project execution throughout all phases of the clinical study, taking overall responsibility of allocated sites,
- ensuring that clinical studies are conducted at clinical sites in compliance with the current approved protocol and any protocol amendment/-s, GCP, SOPs and applicable country laws and regulatory requirements,
- conducting all types of monitoring visits (both- remote and onsite) to clinical sites in accordance with the Protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements,
- ensuring that the reported study data is accurate, complete, and verifiable from source documents,
- maintaining regular site management by communicating with Investigators and site personnel on issues related to the project execution, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance,
- managing and maintaining information and documentation in systems which are used in the project (e.g. CTMS, eTMF) as per project specific plans and timelines,
- communication with the Project Manager, Client, Investigators and suppliers (if applicable),
- maintaining appropriate documentation related to the clinical site management,
- quality control, preparation for and attendance at Clinscience, Sponsor’s and Regulatory audits,
- acting as a mentor to less experienced colleagues, by for example performing co‐monitoring visits.
- medical or life science education (medicine, pharmacy, biology or similar),
- 2-3 years of CRA I experience,
- experience in clinical trials in oncology will be an asset,
- knowledge of ICH-GCP and ISO 14155:2020 guidelines,
- very good English skills, both spoken and written,
- excellent communication, interpersonal, planning & organization skills,
- good computer skills with good working knowledge of a range of computer programs,
- desire and ability to travel.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career. We offer job for full FTE, flexible working arrangements (Permanent– Home/Office based). We are looking for candidates based in South-East Poland, South Poland and Warsaw.
Grupa NEUCA to jedna z największych firm medycznych, rozwijająca się w kilku kluczowych obszarach rynku zdrowia. Daje to naszym pracownikom możliwość tworzenia innowacyjnych rozwiązań, poprawiających jakość życia pacjentów.
W całej Polsce jest nas
leków obecnych w polskich aptekach przeszła przez hurtownie NEUCA
z nas uważa, że w firmie istnieją możliwości zaangażowania się w zadania i projekty pozwalające rozwijać nowe umiejętności