CROMSOURCE Jobs 2017 – Clinical Research Associate, Poland
CROMSOURCE is a high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries, specialized in clinical development and staffing solutions. Since 1997 CROMSOURCE has been supporting clients with outstanding clinical research and staffing solutions services.
CROMSOURCE – Oncology TalentSource Life Sciences is currently searching for an experienced Clinical Research Associate (CRA) for our customer, one of top 20 pharmaceutical companies.
Job Title: Clinical Research Associate
Job Location: Poland
Educational Qualification: Degree level (biological sciences, pharmacy or other health-related discipline preferred).
Years of Experience:
- Min 2-3 years of the relevant CRA experience
- Oncology experience will be additional advantage
- Perform feasibility analysis;
- Preparation/submission/follow up of Regulatory approval process;
- Contract negotiation with Investigator site;
- Interface with the project management team to ensure that each clinical study site can or will achieve optimal outcome as defined by the Sponsor;
- Conduct all pre-trial activities, including pre-study visits;
- Conduct on-site study initiation visits, interim monitoring visits and study closure visits;
- Monitoring the study status and the correctness of study conduct, especially compliance with the study protocol and ICH GCP guidelines by direct meetings with investigators and other people engaged in the study. Monitoring will be performed in accordance with the Study Protocol;
- Review and collect (e)CRFs;
- Perform drug or device accountability;
- Complete Monitoring Visit Reports;
- Administration of the clinical trial, collection of required critical documents, checking and archiving study files;
- Timely distribution of queries to investigators and executing answers;
- Report incoming SAEs and follow-up of activities connected to SAEs reporting;