Study Start Up Associate Ii

5 giorni fa

Milano, Italia Icon plc A tempo pieno

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
- 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).
- Recognize, exemplify and adhere to ICON’s values of Accountability and Delivery, Collaboration, Partnership and Integrity, which center around our commitment to Ownership.
- Travel (approximately 5%) domestic and/or international. Anticipated activities may include attendance at kick-off, investigator or study team meetings.
- Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.
- Perform timely and accurate task progress communication and data entry of all relevant study start up activities into the appropriate tracking system.
- For specific projects, serve as the main point of contact with Sponsor, Project Manager, Clinical Trial Manager, Site Activation Lead, other functional leads and third parties. Work with key stakeholders to optimize performance and collaborate to ensure successful project outcomes.
- Assume responsibility as Subject Matter Expert (SME) as required.
- Coordination of all necessary translations required for any start-up documentation.
- Attend study team meetings as required.
- Other duties as assigned
- Responsible, as assigned, for one or more of the following tasks related to each of the key study start-up and/or maintenance activities:

- Preparation, review and approval of Subject Information Sheets (SIS) and Informed Consent Forms (ICF):
Prepare, review and approve Global Master ICF templates for Sponsors, coordinate with Clinical Trial Manager and/or Site Activation Lead through to approval by Sponsors.

Prepare, review and approve Country Master ICF templates inserting any required country elements, coordinate with Clinical Trial Manager and/or Site Activation Lead through to approval by Sponsors. Escalates any legal or clinical language discrepancies with Legal and/or Clinical team for approval as applicable.

Proficiently negotiate Informed Consent Forms (ICF) with Study Sites to ensure the Site Specific ICF meets local requirements and contains all required elements from Country Master ICF. Escalates any legal or clinical language discrepancies with Legal and/or Clinical team for approval as applicable.

Proficiently review, negotiate and approve all Ethics Committee (EC), Institutional Review Board (IRB) and Competent Authority (CA) queries to Country and Site Specific ICFs.

Proficiently prepare, review and approve amended Global, Country and Site Specific amended ICFs.
- Negotiation and Execution of Clinical Trial Agreements (CTA):
Prepare, and review Study Site level budgets and contract templates and facilitate finalization and approval with the Sponsor, Legal, and any applicable internal personnel.

Proficiently negotiate CTAs, budgets and ancillary agreements.

Proficiently oversee all contractual documents and correspondence, including the facilitation of the indemnification process between Sponsor and Study Site.

Establish and maintain effective and proactive communication with Study Sites, Sponsors and internal personnel regarding the status of budgets, contracts and any other contract-related documents.

Ensure CTAs, budgets a

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