Job Description
We are seeking a **_Regulatory Specialist II_** who will be responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files. This role will serve as a central resource for faculty conducting clinical research.
**Specific Duties & Responsibilities**
+ Collaborate with the Research Nurse and/or Principal Investigator to ensure timely and accurate submissions to the IRB and study sponsors.
+ Obtain and prepare all required documents for new IRB submissions, including initial study submissions.
+ Oversee the smooth implementation of new clinical trials from study conception through activation.
+ Coordinate with the protocol compliance team to ensure readiness of regulatory documents prior to study initiation.
+ Collect all required regulatory documents from participating sites when JHU/JHM serves as the coordinating center, ensuring timely collection
+ Develop and maintain standard operating procedures (SOPs).
**Specific Duties & Responsibilities**
+ Collaborate with the Research Nurse and/or Principal Investigator to ensure timely and accurate submissions to the IRB and study sponsors.
+ Obtain and prepare all required documents for new IRB submissions, including initial study submissions.
+ Oversee the smooth implementation of new clinical trials from study conception through activation.
+ Coordinate with the protocol compliance team to ensure readiness of regulatory documents prior to study initiation.
+ Collect all required regulatory documents from participating sites when JHU/JHM serves as the coordinating center, ensuring timely collection
+ Develop and maintain standard operating procedures (SOPs).