17 ene
Parexel
Nuevo Casas Grandes
.Responsible for supporting the SRPs and investigator for Targeted Sites:**Clinical Trial Site Activation & Conduct**- Assist with study site activation activities to ensure timely site activation- Register investigator sites in Client registries, as required- Support and/or coordinate central Investigator Review Board (IRB) submissions when needed.- Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information,
IRB submission and status- Support local IRB workflow from submission through approval and support reporting of updates to safety information- Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner- Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, Food and Drug Administration (FDA) 1572 revisions, for internal regulatory approval within required timelines- Communicate site approvals to the SRPs, Study Start Up Project Managers (where applicable) and relevant study team members- Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed- Work with investigator sites throughout the study to complete required ongoing study documents such as documents for protocol amendments and FDA 1572 revisions.- Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow- Submit within required timeframes all needed documentation, updates and tracking including, but not limited to, Trial Master File documentation, site activation status,
protocol amendment status.- Problem solve identified issues with appropriate timely escalation to the Site Relationship Partner (SRP)- Assist the SRP with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.- Support investigator sites, SRPs, Study Managers and study teams in preparation for and providingresponses to site audits/inspections**Communication**- Act as a point contact for the GSSO team members for designated project site communications, correspondence and associated documentation- Maintain ongoing contact and communication with the GSSO team members as needed
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