Regulatory Coordinator

 

 The Regulatory Coordinator performs multiple tasks in order to meet compliance requirements in research. This position will be overseeing clinical research regulatory requirements for RIH which may include monitor visit coordination and documentation as well as resolving all regulatory IRB requirements. The Coordinator position is responsible for compiling and organizing regulatory files both manual and computerized in order to access pertinent data and comply with requirements for local Institutional Review Boards and multiple federal agencies.  The Regulatory Coordinator instructs and advises other staff in regulatory/compliance issues as well as provides functional guidance to Clinical Research Assistants and collaborates with investigators to resolve all regulatory inquiries.  

 

BASIC KNOWLEDGE:

Bachelor�s degree preferably in health-related or scientific field is required.

Sound knowledge of all federal local and state guidelines pertaining to Clinical Research. 

Must be an independent person who is capable of making sound judgment pertaining to regulatory issues and have the ability to work independently within the scope of the job requirements.   

Strong-self-starter interpersonal skills and influence are necessary

Team-oriented with excellent oral and written communication skills

Strong problem-solving skills

Excellent self- management and organizational skills

Detail-oriented

Computer skills in Microsoft office

Comprehensive knowledge of FDA regulatory guidelines

Must be proficient in various database applications 

Ability to foster smooth communications and teamwork among clinical research faculty fellows and staff as well as external organizations necessary


EXPERIENCE:

3-5 years in direct clinical trial administration experience or relevant clinical development and regulatory experience

Understanding of compliance requirements with federal state or local programmatic regulations are necessary

 

Lifespan is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status.   Lifespan is a VEVRAA Federal Contractor.

 

Location: Rhode Island Hospital USA:RI:Providence

 

Work Type: Full Time

 

Shift: 1

 

Union: Non-Union


Work Schedule: 

Monday - Friday 8:00am - 4:30pm