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.  

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. 

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, reviewing of informed consent forms and submitting them to institutional review boards, and contract review are desired. 

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.  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.