We are looking for an Regulatory Specialist to work on a full-time basis in support of our Baltimore, MD facility. It’s the opportunity to gain invaluable experience working with clinical research studies and be a part of the clinical research team for emerging breakthrough treatments.
This position is responsible for the overall management of all essential documents for the conduct of a clinical trial, as well as Regulatory and IRB submissions.
- Create and maintain regulatory binders for all assigned studies.
- Create and maintain an up-to-date paper-base and electronic Trial Master File.
- Perform initial IRB submissions (i.e., Protocol, IB, informed consent form, etc.)
- Ensure all start-up documents, IRB approval letters and informed consents are forwarded to the study sponsor in a timely manner.
- Submit informed consent revisions, protocol amendments and clarification letters for IRB approval.
- Submit study related recruitment materials to the IRB for...