Site Activation Partner I - Temporary contract - FSP

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

Key Accountabilities:

Clinical Trial Site Activation:
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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

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Provide support to resolve issues or concerns and timely escalation of site issues where applicable

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Prepare, validate and submit regulatory documents such as completed IIP, Institutional Review Board (IRB) approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines

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Manage and coordinate with other supporting roles to ensure timely site activation and operational activities

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Support the compilation of the Central Investigator Review Board package and submissions to approval of the study (where applicable) and other committees as per country requirements

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Coordinate the timely communication, documentation and responses between client and central ethics committee to bring clinical study to approval (country dependent)

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Support investigators sites with local IRB workflow from preparation, submission through approval

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Assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures

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Support and implement activities in Shared Investigator Platform (SIP) to align with the client’s strategy as it relates to the role

Clinical Trials Conduct:
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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

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Ensure maintenance of IRB/Ethics and other committees’ activities as applicable

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Responsible for timely filing of documents to Trial Master File (TMF) and assisting with periodic quality review of study files for accuracy and completeness

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Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines

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Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections

Communication:
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Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests

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Provide functional updates on a country and site level as required

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Establish tools for effic