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Site Activation Partner Ii
2 settimane fa
ROLE SUMMARY
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 Pfizer standards. Responsibility span within a country or multi-country depending on the geographical region and business needs
ROLE RESPONSIBILITIES
Clinical Trial Site Activation & Conduct
- Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to sites initiation approval
- Register investigator sites in Pfizer 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 complete critical information and readiness for site activation; inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, study contracts contacts, clinical supply shipment information, payment information, IRB submission and status
- Take the lead to resolve issues or concerns and timely escalation of issues where applicable
- Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions, for internal regulatory approval within required timelines
- Lead a subset and assist with the overall site activation process and coordinate operational activities to ensure timely site activation
- Take the Lead and Coordinates the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study
- 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 Clinical Trial Supplies and maintenance of tracking information as needed
- Initiate and coordinate activities and essential documents management with the investigator’s sites (post SIV) during study conduct 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 revisions, Ethics Committee annual approvals
- Responsible for timely filing of documents to Trial Master File and other systems and assist with periodic quality review of study files for accuracy and completeness
- Accurately update and maintain clinical systems that track site compliance and performance within project timelines
- Lead or assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections
Communication
- 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 Ethics Approval to study team and Investigator Sites
- Communicate Local sites approvals to study team members and stakeholders
Clinical Trial Site Support
- As needed, perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards
- Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence / persistence of issues
Additional Responsibilities:
- Deep understanding of the Site Activation requirements and processes within the country and be able to develop and implement in more than one (1) country to enable multi-country coverage.
- Assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multi-country:
- Represent the SAP role on the study
- Take the lead in the compilation and preparation of the Investigator Initiation Package (IIP) Template for the study and share with SAP team globally
- Communicate with SAPs globally on study information and timelines
- Be an SME on one or more system and/orprocess, bethe go-to person and train the SAPs on these respective systems or processes
- Represent the SAP role on global initiatives
- Mentor for new hires on processes, systems and SAP activities facilitating and optimizing the time from hire/training to assignment on a study
- Able to manage a high volume of, complex
