Study Start Up Associate II

Senior SSUA

As a global provider of drug development solutions, our work is serious business. But that doesn’t mean you can’t have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

The role

·        As a member of staff, the employee is expected to embrace and contribute to our culture or process improvement with a focus on streamlining our processes adding value to our business and meeting client needs

·        Travel (approximately 15%) domestic and/or international.

·        Anticipated activities may include attendance at Bid Defenses, Kick-Off, Investigator or study team meetings

·        Perform feasibility , site identification ,site contract negotiation, and other study start up activities. as assigned

·        Provide country specific Study Start Up expertise to Study Stan Up Team Leads and project teams

·        Responsible for the preparation and coordination of submissions to regulatory, ethics and other bodies

·        Develop, finalize and review Master and Country Specific Subject Information Sheet Inform Consent Forms (SICF).

·        Prepare, finalize and review Master and Country Specific EU Clinical Trial Application Forms and corresponding data files in collaboration with other relevant departments (xml file) (EU Only).

·        Review and translate Drug labels

·        Perform independent quality review of submission packages

·        Responsible for the translation and co-ordination of translations for documents required for submission. 

·        Perform timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system 

·        Copy and route incoming correspondence internal documentation etc. , as appropriate

·        Responsible for the timely follow-up for queries made by EC/CA 

·        Responsible for the collection of clinical documents required for IP Release

·        Responsible for the negotiation execution and tracking of contract with sites and others as appropriate.

·        Responsible for the timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system in assigned countries

·        Attend study team meetings as required. including Kick-Off Meeting 

·        Assemble and distribute study materials to Clinical and Project teams.

·        Including materials to study sites and Investigator Meetings (e g : investigator binders) and vendors.as appropriate.(US only)

·        Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee EC submission information and similar information

·        To be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs 

·        Competent in communication and influencing skills to ensure timely follow-up. issue resolving on and report updates, as outlined in the communication and escalation plan with timely documentation  

·        Perform regulatory document maintenance, amendments periodic updates and safety letters, where applicable

·        Develop end maintain effective relationships with local, regional and country authorities 

·        Comply with all department requirements regarding information provision and status updating and reporting 

·        To undertake and fulfill Study Start Up Team Lead role activities as per the Study Start Up ream Lead scope definition 10 preparation for future career progression 10 Study Start Up Team Lead 

·        To undertake other reasonably related duties as may be assigned

Why join us?

Ongoing development is vital to us, and as a CRA you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success. Working for ICON you will be provided with a comprehensive benefits package including premium salary, bonus, 401K with employer match, generous PTO, paid holidays, company cell phone, FSA and college savings plan.

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