Overview

The Study Start Up. Assocate II, collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.
Embrace and contribute to ICON's culture of quality and process improvement with a focus on enhancing processes, systems and tools, adding value to our business and meeting or exceeding client needs.

Responsibilities

What you will be doing:

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 and ancillary agreements are negotiated within the Study specific agreed parameters and if not, appropriate approvals are obtained and documented.
  As required, proficiently prepare, review and negotiate amendments to CTAs, budgets and ancillary agreements.
- Conduct second level quality control review of completed CTAs, budgets and ancillary agreements prior to execution.
- Serve as the internal liaison on study site budgets with respect to country needs and requirements.
- Forecast Budget and Clinical Trial Agreements execution timelines and ensures they are achieved; provide risk assessment and contingency plans to mitigate impact if forecasted timelines are not reached, and escalate issues as soon as identified.
  Prepare, review and negotiate Master Service Agreements with sites.
- Competent Authority (CA), Ethics Committee (EC) and Institutional Review Board (IRB) Submissions: Proficiently 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.
- Effective 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 risk and contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified.
- Preparation, Submission, Review and Approval of Critical Document Package (CDP):
- Proficient 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.
  Accurately forecast CDP Approval timelines and ensure they are reflected accurately in ICON's systems, proactively follow through for achievement to plan; provide risk assessment and contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified.
- Ensure accuracy and timely 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 TMF.

Qualifications

You are:

G-Bachelor's Level Degree
Bachelor's degree in a health, life sciences or medical fields.
At least 2-3 year of experience with study start-up - regulatoy activities in clinical research market.
Fluent English and Spanish (read, write and speak).

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, 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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.