The associate provides technical support to the clinical trial capabilities team in support of clinical development. The associate is responsible for activities related to investigator sites readiness, maintenance, and closeout. You will ensure inspection readiness through a complete, accurate, and readily available Trial Master File. Additional country-specific responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

Clinical Trial Responsibilities:

• Initiate investigator site activities, including collection and submission of regulatory documents, customization, and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain a fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
• Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
• Identify, communicate, and resolve issues
• Ensure country-specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
• Leverage previous site/review board engagements to efficiently drive new work
• Populate internal systems to ensure accuracy of trial/site performance
• Understand and comply with procurements, legal and financial requirements, and procedures
• Populate Trial Master Files and libraries for future reference
• Provide feedback and shared learning for continuous improvement
• Leverage trial prioritization
• Anticipate and monitor dynamically changing priorities.

Qualification Requirements:

• Bachelor’s degree preferably in a scientific or health-related field, two years clinical research experience or relevant experience preferred
• Understanding of the overall clinical development paradigm and the importance of efficient site initiation
• Applied knowledge of project management processes and skills
• Appreciation of / experience in a compliance-driven environment
• Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
• Effective communication, negotiation, and problem-solving skills
• Self-management and organizational skills
• Fluency in Spanish