Study Start Up Associate I

• Review of site level essential documents ensuring that Sponsor and Investigator obligations are being met and are in compliance with ICON SOPs/WIs, Sponsor SOPs, applicable country requirements and ICH/GCP guidelines.

• Update systems in a timely and accurate way, maintaining site-related data in applicable clinical systems according to procedures and guidelines.

• Preparation and Submission of Investigational Product Release Pack.  

• Ensure accuracy and timely completeness of Trial Master File (TMF) documents by submitting the documents for filing to TMF during start-up.

• Perform timely and accurate task progress communication.

• Be highly organized in an environment with shifting priorities.

• Interact successfully with internal stakeholders.

• Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study- specific processes, local regulatory requirements.

• Flexible to support on various other tasks apart from document management process

• 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 do you need to have?

• Bachelor’s Degree in a life science related field or relevant/equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.

• Knowledge of ICH GCP and Prior clinical research experience with a minimum of 1-4 years’ experience in Essential Document review, filing documents in TMF and checking TMF completeness and readiness.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.