Sr Study Start Up Associate

Study start up associates are integral in ensuring that clinical research sites are prepared and have the necessary tools and approvals needed to start the trial of investigational, new pharmaceutical and biological products for clinical trials. Study Start-Up is often the first operational service delivery client teams experience when they work with ICON for the first time.  This role defines how you can help ICON to become a market leader in this aspect of clinical trial delivery by working in partnership with the feasibility, site identification, and start-up teams to reduce the time it takes to select, prepare, and initiate study sites to recruit patients in our clinical trials.

As a Study Start up Associate you will be responsible for the independent preparation, review and approval of country-related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines. This role is also responsible for the independent preparation, review and approval of site level critical documents for investigation drug release in accordance with regulatory and sponsor requirements. You would also be involved in the site start up activity for clinical research, investigative sites.  You would play an important role in ensuring clinical sites are ready for the first day that the drug trial begins.  You will prepare the regulatory binder, ship investigational product, ensure that all documentation is ready an available at the site, and make sure that sites are ready to be activated to enroll their first study patient. 

We are looking for someone who has experience working in a clinical environment and who is responsible to handle a variety of tasks in a short time frame.  You should have knowledge of how an investigative study is run as well as regulatory requirements.  We prefer someone with a bachelor’s degree and a clinical background with strong clinical site management experience. Study start up experience is a plus.  Experience collecting and submitting regulatory documents and communicating with investigative sites is preferred.  This an exciting opportunity to work within a fast paced, busy study start up clinical group for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.  

Increasing competition and regulatory demands are putting more and more pressure on pharmaceutical companies and medical device manufacturers to reduce the product development timelines.  You can be part of the solution to drive efficiency and improve results for our partners and ultimately for the population the investigational product may eventually serve.  We are a company of 13,500 employees in forty countries globally.  We differentiate ourselves by developing innovative solutions to bring life-saving drugs to market faster and in a more cost-effective way to foster better patient outcomes.  We are a top five clinical research organization with solid earnings and growth potential.  Our belief in excellence is our core value in all that we do for our sponsor partners and the patients that we serve.  As a company we strive to exceed our customers’ expectations in drug development solutions. 

Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent retirement plan, health coverage, paid time off, income protection insurance programs, and staff recognition schemes.  We care about our people, since 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.  Caring for patients while enjoying what we do and delivering great results is something we can achieve if we know we can count on each other and have a clear vision of where we want to go.

ICON is an equal opportunity employer – Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.