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 65-75% 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:
Applicant should possess a B.S. degree in life science, nursing or an equivalent
education and work experience (RN or LPN with at least 4 year of field monitoring experience).
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.
Ability to travel overnight, primarily in the U.S., 3+ days per week on average.
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.
Benefits of working with ICON
Working for ICON you will be provided with an excellent benefits package.
ICON enjoys a strong reputation for quality and focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
Clinical Research Associate
US-Dallas (TX), US-New Orleans (LA), US-Austin (TX), US-San Antonio (TX)
Clinical - Operations
18/Dec/12, 11:04:36 AM
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