Study Start Up Associate I

Recognize, exemplify and adhere to ICON's values of Accountability and Delivery, Collaboration, Partnership and Integrity which center around our commitment to Ownership.
* The employee is expected to embrace and where possible contribute to our culture of continuous process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.
* Travel (approximately 5%) domestic and/or international. Anticipated activities may include attendance at kick-off, investigator or study team meetings.
* Working 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.
* 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:
o 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.
o 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.
o 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.
o 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 achieved; provide contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified.
§ Ensure accuracy and completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.