Senior CRA

Proclinical is seeking a Senior CRA for a for a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Working within a highly qualified team the 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.

Job Responsibilities:

• 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

Skills and Requirements:

• 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 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.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sarah Fenanir on +44(0) 2 203 846 0643 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.