Regulatory Specialist

The Regulatory Specialist is responsible for filing and maintaining of all critical documents related to study conduct

• Prepares study specific regulatory documents for IRB submission.
• Submits all Informed Consent Revisions and protocol amendments for IRB approval
• Submits all study related recruitment materials to the IRB for review and approval
• Submits initial  Investigator Brochure and any revisions throughout the course of the study
• Oversees the reporting and  tracking  of all study deviations/violations and Serious Adverse Events to IRB and Sponsor
• Ensures sponsor safety letters are submitted to the IRB
• Oversees preparation of all closed study files for archiving in long term storage
• Adherence to Good Clinical Practices (GCPs) and SNBL-CPC’s Standard Operating Procedures (SOP’s).

Qualifications:
Bachelor degree in science or related field

1-3 years experience work with IRB’s

Category:	Biotech/Pharmaceutical
	> Clinical Research      > Clinical Data Management      > Regulatory Affairs      > Document Control      > Research & Development
Location:	Baltimore, MD
County:	Baltimore City County
ZIP Code:	21201
Pay Rate:	Open
Job Terms:	full time
Company:	SNBL Clinical Pharmacology Center, Inc.
Phone:	email only
Fax:	410-706-8963