Site Activation Specialist II, Israel, FSP, client-dedicated, home-based, perm, full-time

Description

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 client standards. Responsibility span within a country or multi-country depending on the geographical region and business needs.

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 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 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 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 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
  
  

• 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
  
  

• 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 client 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
  
  

• 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/or process, be the 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 studies and sites
  

• Min BS/BA or bachelor’s degree, higher degrees in life sciences are preferred
• Previous relevant experience in Clinical Trials environment and clinical site activation. Experience working in the pharmaceutical industry/or CRO is an asset
• Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
• Must be fluent in Hebrew and in English.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
• Good technical skills and ability to learn and use multiple systems
• Experience in working in more than 1 country is an asset
  
  

• Demonstrated knowledge and understanding of key operational elements of a clinical trial and processes (e.g., study start-up, conduct, close-out activities, reporting, etc.) and ability to gain command of these processes
• Understand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements. Attention to detail evident in a disciplined approach
• Proven ability to work independently and also as a team member
• Ability to organize tasks, time and priorities, ability to multi-task
• Understand basic medical terminology, GCP requirements and proficient in computer operations.
  
  

• Reports to Site Activation Partner Manager
• Partners across Global Site and Study Operations roles, and other CD&O roles as needed
• Partners with Regulatory Affairs, PharmSci, Medical Quality Assurance, Legal, Drug Safety Unit as needed