- Ogłoszenie wygasło miesiąc temu
- Umowa o pracę
- Pełny etat
- Specjalista (Mid / Regular)
As a global Contract Research Organization with 15 years of experience, Clinscience is growing at a fast pace both organically and via acquisitions. We combine the knowledge and experience of medical, biostatistics, regulatory and clinical operations experts, to effectively conduct the end to end clinical research processes. Clinscience CRO is part of Neuca Group, the public healthcare company listed on the Stock Exchange focused on developing patient-centric businesses. We are focused on technology and having the patient at the center of our interest and operations. At Clinscience, you really can make a difference and we are committed to providing the very best career development opportunities that encourage you to progress in the direction of your strengths and aspirations. Whether you’re looking to develop your technical expertise, project leadership or line management skills, we work with you to help you achieve your goals.
Clinscience is currently looking for a person for the position of:
- 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);
- 2-5 years of CRA II experience;
- experience in clinical trials in oncology;
- 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 also looking for candidates not based in Warsaw.
If you are interested in this position, please apply.