Study Start Up Associate I

hace 5 meses

Ciudad de México ICON plc A tiempo completo

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 organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization 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.

**Title**: Study Start Up Associate I (SSU I)

**Summary**: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.
- Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirement
- Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager - Central Services or Designee.
- Preparation, review and approval of Subject Information Sheets (SIS) and Informed Consent Forms (ICF):

- Be involved as required in the preparation, review and/or approval of Country Master ICF templates.
- 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.
- Review, negotiate and approve all Ethics Committee (EC) and Institutional Review Board (IRB) queries to Site Specific ICFs.
- Prepare, review and approve amended Site Specific amended ICFs.
- Negotiation and Execution of Clinical Trial Agreements (CTA):

- Prepare, review and negotiate CTAs, budgets and any required ancillary agreements with assigned Study Sites.
- Prepare and 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 and internal personnel regarding the status of budgets, contracts and any other contract-related documents.
- Ensure CTAs, budgets and ancillary agreements are negotiated within the Study specific agreed parameters and if not appropriate approvals are obtained and documented.
- As required, prepare, review and negotiate amendments to CTAs, budgets and ancillary agreements.
- Forecast Budget and Clinical Trial Agreements execution timelines and ensure they are achieved; provide risk and contingency plans to mitigate impact if forecasted timelines are not reached, and escalate issues as soon as identified.
- 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, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
- Interaction with Ethics Committees, Institutional Review Boards and Country Regulatory Agencies (Competent Authorities) to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct (start up and maintenance as assigned).
- Forecast submission/approval timelines and ensure they are achieved; provide contingency plans to mitigate impact if forecasted timelines are not reached, and escalate issues as soon as identified.
- Preparation, Submission, Review and Approval of Critical Document Package (CDP):

- Essential document collection and review, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable country requirements and ICH/GCP guidelines.
- Preparation and submission of site level critical documents which are part of the Critical Document Package (CDP) to the Central CDP Review Team (CDPRT) and Sponsor.
- Review and approval of Critical Document Package (CDP).
- Investigational Product (IP) release in accordance with regulatory and Sponsor requirements.
- Forecast CDP Approval timelines and ensure they are reflected accurately in ICON’s systems and are achi

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