Senior Study Start-up Associate

• Industry Pharma/Biotech/Clinical Research
• Remote Job

This is a remote position.

• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
• With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements
• May support / assist the contract negotiation process under supervision of an experienced colleague or line manager
• Escalate study issues appropriately and in a timely fashion
• Update study documents when there are changes in study personnel/study amendments
• Contribute to the preparation of submissions to IRB/IEC with appropriate supervision
• Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making the company ready for an audit at any time
• Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision

Experience

• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
• Minimum 3 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
• Demonstrated basic understanding of the clinical trial process