CRA /oncology
Warszawa
NR REF.: 1019346

My client is a big R&D company which carries out clinical research in Central Europe. The company's clients include global pharmaceutical companies which outsource clinical research to contract research organizations.
Currently they are looking for experienced candidates for the position of:


Clinical Research Associate /oncology – Warsaw

CRA – office-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

Travel Required:

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.

Education / Qualifications Required:

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 two 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;