Site Activation Partner
hace 2 semanas
Job ID R
Category Clinical Trials
ABOUT THIS ROLE:
The FSP division of Parexel FSP is seeking a Site Activation Partner based in Spain.
Position Purpose:
- The Site Activation Partner is responsible for leading or supporting operational activities from startup to closeout, 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
Primary Responsibilities:
Clinical Trial Site Activation
- Initiate and coordinate activities and essential documents management during startup towards the compilation of a highquality 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 startup by reviewing study site profile ready in Shared Investigator Platform (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 status
- 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 activities
- 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 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 preparation, handling and distribution of nonClinical Trial Supplies and maintenance of tracking information as needed
- Collaborate with the Study Team on the development and readiness of sites electronic Investigator Site File (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 Site Initiation Visit (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 SIP to align with Client strategy as it relates to the role
- Coordinate translation of documents that are within scope with the preferred translation vendors
- Post site activation, initiate and coordinate activities and essential documents management with the investigator's sites towards the compilation of a highquality 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
- As needed, perform, awareness session with site personnel on Client requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Client standards
- Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues
- Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system and process related training
- Adhere to EP and Client SOPs and processes
- A good understanding of the Site Activation requirements and processes within the country/region and be able to learn and potentially implement in more than one (1) country
- May be assigned as Site Activation Partner Point of Contac
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