Study Start Up Associate I/study Start Up Associate Ii

2 days ago

Chennai Tamil Nadu, India ICON Plc Full time

Study Start Up Associate Level I & Level II

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

Study Start Up Associate.
As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

What you will be doing-
- Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.- Maintaining accurate and up-to-date records of regulatory submissions and approvals.- Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.- Participating in study start-up meetings and providing input on regulatory requirements and timelines.- To review and negotiate clinical site investigator contracts and budgets.- Stay connected with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents- Prepare and coordinate preparation of contractual documents and correspondence- Facilitate the indemnification process between the study sponsor and the site.- Function as the internal consultant on study budgets (investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the SSU department, and act as consultant on the Investigator Contract and Budget development process from origination through execution).

What you need:
- Knowledge of ICH GCP and Prior clinical research experience with a minimum of 2-6 years’ experience in Essential Document review (Study Start Up)- Added Advantage:
- Experience working with different countries- Proficiently review, negotiate and approve all Ethics Committee (EC), Institutional Review Board (IRB) and Competent Authority (CA) queries to Country and Site Specific ICFs.

LI-AB2

What ICON can offer you:

- Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
- In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
- Our benefits examples include:
- Various annual leave entitlements- A range of health insurance offerings to suit you and your family’s needs.- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.- Life assurance- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our

careers site

to read more about the benefits ICON offers.

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