Senior Clinical Research Associate

CLINICAL RESEARCH ASSOCIATE II

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.   
• Depending on your level of experience, you may assist in training and mentoring less experienced CRA’s.
• 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
• Approximately 65% travel overall can be expected, regional and national.
• In line with our philosophy of providing the highest quality to our clients, CRAs are typically assigned to one to two programs at a time.

 Role Requirements / Skills / Experience:

• Bachelor’s degree, or local equivalent, in medicine, science or related discipline. Or RN or LPN with at least 4 year of field monitoring experience.
• Applicants must have at least 2 years of experience independently monitoring clinical trials.
• Knowledge of ICG GCP guidelines and the expertise to review and evaluate medical data.  
• Possess excellent written and verbal communication and interpersonal skills enabling you t deal with queries in a timely manner.
• You should be able to produce accurate work to tight deadlines within a pressured environment.
•  Will consider CRAs for home-based offices if he/she has at least 6 months of verifiable home-based experience and high-speed connectivity in the home office as part of above qualifications.
• Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid drivers license

Benefits of working with ICON

Working for ICON you will be provided with an excellent benefits package.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   

In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment