Description
Roles and Responsibilities:- Collect, review and process regulatory documents such as informed consent forms, FDA form 1572s, curriculum vitae, financial disclosure forms, IRB/EC approvals and correspondences, etc., and ensuring that said documents meet requirements set forth in all applicable regulatory guidelines (e.g., FDA and EU Clinical Trial Directive regulations, ICH-GCP, ARIAD SOPs and working practice guidelines, etc.)
- Initiate and manage shipments of investigational drug and other clinical trial related supplies
- Maintain tracking tools and spreadsheets of required investigative site regulatory documents and contact information
- On an as-needed basis, participate in routine monitoring visits of clinical and laboratory centers to review protocol adherence, data reporting accuracy, adequacy of study records, and accountability/tracking of clinical trial materials such as investigational drug and biological specimens
- Assist with the preparation of study amendments, model informed consent forms, laboratory manuals, and other clinical trial related documents as assigned
- Maintain and coordinate generation of clinical trial status reports and tracking spreadsheets and/or databases
Requirements:
- BS or degree in a related field
- At least 1-2 years of prior CTA or CRA experience is essential
- Proficient oral and written communication skills
- Must be available for travel when it requires (less than 10%)
To find out more about Real please visit www.realstaffing.com