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 ICG GCP guidelines and the expertise to review and evaluate medical data.
- Fluent in English, as well as the local language, 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 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.