ICON Clinical Research Study Start Up Associate II in Auckland, New Zealand
"At ICON, it's our People that set us Apart"
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. As a SSU 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 and ethical standards. Developing and finalizing Master and Country Specific Information Sheets/Informed Consent Forms (SIS/ICFs)
Currently we are hiring the Study Start Up Associate II role in New Zealand.
Serving as a primary contact for investigators and research coordinators, you will perform feasibility, site identification, site contract negotiation and other assigned study startup activities. This will include the preparation, review and approval of country related ethics/regulatory submission packages and site level critical documents for Investigational Product (IP) release. Some travel is anticipated, to attend Kick-Off, Investigator and/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 Start Up Team Leads and project teams.
Responsible for the preparation and coordination of submissions to ethics and other bodies
Develop, finalize and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs)
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
Responsible for the collection of critical documents required for IP Release
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 Responsible for the collection and maintenance of the current Ethics Committee (EC) submission information, and similar information for other related.
Develop and maintain effective relationships with local, regional and country authorities
Comply with all department requirements regarding information provision and status updating and reporting
Travel(approximately 15%) domestic and/or international. Anticipated activities may include attendance at Bid Defences, Kick-Off, Investigator or study team meetings.
Knowledge and experience in the clinical study start up requirements and activities for all assigned countries (or the ability to find this out for new countries)
Good organizational skills and the ability to manage multiple tasks
An excellent level and proven experience high standards of attention to detail
Good written and verbal communication skills. Proficient in English and language required for country assignments
Ability to liaise with colleagues from Study Start Up, other departments and clients, if required
Strong project management skills
Highly developed problem solving skills
Strong people management and effective communication skills
Customer service focused
Bachelor’s degree or local equivalent and/or with appropriate experience from the Medical/science background and/or discipline
Comparing with our competitor and pharmaceutical companies, we provide more flexible and reasonable working platform for coach and educate the new comer to be a professional person to concentrate on relevant industry. ICON also provides the good package and benefit to adapt the marketing development.
We more like a whole family with kind-heart and warm carefulness which you can balance your life and work here.
If you want to review more please visit our company website: www.iconplc.com or careers.iconplc.com. Or you can send the email to me directly: Jennifer.email@example.com
Welcome to join ICON.