Senior Clinical Research Associate / CRA II Location : Warsaw Poland (office or home based anywhere in Poland)) This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.
Working within a highly qualified team our Clinical Research Associates (CRA's) identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV ensuring adherence to applicable regulations and principles of ICH-GCP. Overview of the Role
Working independently and proactively to coordinate all necessary activities required for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation.
You will be involved in the submission of protocol, consent documents for ethics / IRB approval and assist in the preparation of regulatory submissions as requested
Managing sponsor generated queries efficiently and taking responsibility for study cost effectiveness; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required.
Depending on your level of experience, you may assist in training and mentoring less experienced CRA's and / or manage CRA's working on international projects
With a University degree in medicine, science, or equivalent; you will have previous monitoring experience in medium sized studies, including study start-up and close-out (for all roles above Entry Level).
You should also have knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data
You will possess excellent written and verbal communication and interpersonal skills enabling you to deal with queries in a timely manner.
You should be able to produce accurate work to tight deadlines within a pressurised environment
You must be available to travel at least 60% of the time (international and domestic -fly and drive) and should possess a valid driving licence
You will be fluent in both English and Local language written and spoken.
You will have the opportunity to progress your career and may wish to move into Project Management or into other related areas where you can further develop your skill set.