Study Start Up Associate II

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Study Start Up Associate II
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.

The Role
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.

Responsibilities:

Preparation, Review, and Approval of Subject Information Sheets (SIS) and Informed Consent Forms (ICF):

• Assist in the preparation, review, and approval of Country Master ICF templates.
• Negotiate ICFs with Study Sites to ensure compliance with local requirements and inclusion of all necessary elements from the Country Master ICF. Address any legal or clinical language discrepancies with the Legal and Clinical teams.
• Review, negotiate, and approve all Ethics Committee (EC) and Institutional Review Board (IRB) queries related to Site Specific ICFs.
• Prepare, review, and approve amended Site Specific ICFs.

Competent Authority (CA), Ethics Committee (EC), and Institutional Review Board (IRB) Submissions:

• Collect, review, organize, and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, and other local regulatory authorities as required by countries, in accordance with ICH/GCP and applicable country regulations/guidelines.
• Interact with Ethics Committees, Institutional Review Boards, and Country Regulatory Agencies to obtain necessary authorizations/approvals for clinical trial conduct.
• Forecast submission/approval timelines and provide contingency plans to mitigate any potential delays, escalating issues as needed.

Preparation, Submission, Review, and Approval of Critical Document Package (CDP):

• Collect and review essential documents to ensure compliance with Sponsor and Investigator obligations and applicable country requirements and ICH/GCP guidelines.
• Prepare and submit site-level critical documents as part of the CDP to the Central CDP Review Team (CDPRT) and Sponsor.
• Review and approve the CDP.
• Oversee Investigational Product (IP) release in accordance with regulatory and Sponsor requirements.
• Forecast CDP Approval timelines and ensure accurate reflection in ICON’s systems, providing contingency plans for any potential risks and escalating issues as identified.
• Ensure accuracy and completeness of Trial Master File (TMF) documents during start-up and conduct Quality Control (QC) reviews before transferring files to maintenance for filing in the TMF.

Qualifications:

• Bachelor’s Degree, preferably in Life Sciences.
• SSU experience is desirable but not required.
• Minimum of 1 year’s experience or understanding of clinical study start-up requirements and activities.
• Fluency in English and Polish; additional European language skills are an advantage.

What you need
• Bachelor’s Degree preferably in Life Sciences
• SSU experience is desirable but not required.
• Minimum of 1 years’ experience or understanding of clinical study start up requirements and activities.

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.

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