Nr Ref.: 1009380
Currently they are looking for experienced candidates for the position of:
Clinical Research Associate – Poznań area, home-based
Summary of Job Specification:
Conducts site monitoring of clinical research studies according to Standard Operating Procedures and GCP Guidelines
Job Duties and Responsibilities:
- Responsible for all aspects of study site monitoring including: routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaising with vendors
- Conducts feasibility work
- Monitors Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Independently performs CRF review; query generation and resolution against data review guidelines
- Available for travel from 50% to 80% of the time, including overnight stays as necessary, consistent with project needs and office location.
- Ability to drive and have a valid driver’s license.
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
- Knowledge of GCP, monitoring procedures, basic understanding of regulatory requirements.
Experience / Skills Required:
- Minimum of one and a half (1,5) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
- Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP.
- Good planning, organization and problem solving abilities.
- Ability to work with minimal supervision.
- Good communication and interpersonal skills.
- Good analytical and negotiation skills.
- Computer competency.
- Fluent in local office language and in English, both written and verbal.