Study Start Up Associate II

“At ICON, it's our People that set us Apart”

Are you passionate about improving the quality of human life? If so, we invite you to join us in creating a healthier world tomorrow.

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.

We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.

Job Title                               : Study start up associate

Reporting to                      : Manager

Location                               : Chennai/Trivandrum

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.  

SSUA Contract and Budgets

As a study start up associate at ICON working in contracts and budgets team, your main role would be to review and negotiate clinical site investigator contracts and budgets.  You would maintain communication with Investigative sites, sponsors and internal teams regarding the status of contracts and contract-related documents, prepare and/ or oversee preparation of contractual documents and correspondence, and facilitate the indemnification process between the study sponsor and the site.  Further you would serve as the internal point of contact on study budgets with respect to investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the study start up department, and act as a point of contact on the Investigator Contract and Budget development process from origination through execution.    

We are looking for associates who have experience in a clinical research environment with specific experience in study contracts review and budget negotiation or experience in a related field such as where contract or legal document review was a primary function.  

Qualification: A bachelor’s degree in Paralegal Studies, Juris Doctor (law) degree, or related experience is preferred.  Study start up experience is desirable but not mandatory.  

SSUA Regulatory submissions

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 includes independent preparation, review and approval of site level essential documents for investigational 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 will 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. 

Qualification: We prefer someone with a bachelor’s degree and a clinical background with strong clinical site management/ study start up experience. Experience collecting and submitting regulatory documents and communicating with investigative sites is preferred. 

As a Study Start Up Associate at ICON working as an Informed Consent Form Reviewer your main role would be to review Informed Consent Forms and negotiate language as needed.  You will assist in the drafting of ICF country templates for the United States and Canada, which will then be distributed to study sites to make edits depending on their local IRB requirements and SOPs. You will review and negotiate these changes and potentially liaise with other stakeholders like the sponsor, legal, or the clinical team to ensure that changes to the ICF are acceptable.

Qualification: We prefer someone with a bachelor’s degree and a clinical background in clinical research at a CRO, Pharmaceutical company, study site, or who has worked in an IRB. Your experience must include performing ICF review as an essential function of the job. 

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 pension scheme, private health care, and life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. 

When you spot an opportunity you’re interested in and submit an application, one of our Talent Acquisition Specialists will contact you to evaluate your suitability for this position, as well as for other openings within the business.

The evaluation will look at your technical skills and your competencies – for example, delivering excellence.

After this, we’ll let you know if we’ll be progressing with your application. If you have been successful at this stage, we will talk you through a telephone interview. This will then be followed by an interview with our Hiring Manager, either face to face or by tele-conference.

If you’re successful, we will notify you with details of the offer, talk you through our culture and values, answer any questions you may have – and above all, welcome you to the ICON team.