In-house Cra 2

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and client standards. Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs.

**Clinical Trial Site Activation**
- Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.
- Register investigator sites and client stakeholders in client registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready.
- Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in SIP or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and
- Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable.
- Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
- Manage and coordinate with other supporting roles to ensure timely site activation and operational
- Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (_where applicable_) and other committees as per country requirements.
- Coordinate the timely communication, documentation and responses between Pfizer and Central Ethics committee to bring clinical study to approval (country dependent).
- Support investigators sites with local IRB workflow from preparation, submission through approval.
- Assist with preparation, handling and distribution of non-Clinical Trial Supplies and maintenance of tracking information as
- Collaborate with the Study Team on the development and readiness of sites eISF when utilized and act as primary point of contact for the sites and manage the Site Operations/CRO monitor access to eISF prior to SIV.
- Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Support & implement activities in Shared Investigator Platform to align with client strategy as it relates to the role.
- Coordinate translation of documents that are within scope with the preferred translation

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**Clinical Trials Conduct
- Post site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, Ethics Committee annual approvals and other activities required during study conduct.
- Ensure maintenance of IRB/Ethics and other committees’ activities as applicable.
- Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness.
- Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines.
- Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections.

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**Internal & External Communication**

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- Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests.
- Attend study Start-up meeting and provide functional updates on a country and site level.
- Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals.
- Disseminate Central or Local Ethics Approval to study team and Investigator Sites where applicable.
- Communicate Local sites approvals to study team members and stakeholders.

**Clinical Trial Site Support**
- As needed, perform, awaren