Site Activation Partner I - 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. Key Accountabilities: 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 Provide support to resolve issues or concerns and timely escalation of site issues where applicable 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 Manage and coordinate with other supporting roles to ensure timely site activation and operational activities 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 Coordinate the timely communication, documentation and responses between client 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 the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures 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: Post site act