Job Description
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
Requirements
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