Regulatory Coordinator

U.S. Urology Partners•Syracuse, NY

17h•Onsite

About The Position

We are seeking a Clinical Research Regulatory Coordinator (CRRC) who is enthusiastic about clinical research and thrives in a team environment. The Clinical Research Regulatory Coordinator will be responsible for maintaining clinical trial regulatory documents and ensuring all sites adhere to the ICH-GCP guidelines and site operating procedures. The CRRC will also assist with the maintenance of staff documentation and site-specific certifications. The successful applicant will be extremely organized, can communicate effectively with multiple clinical research staff, collaborate with external vendors, and enjoy working in a dynamic work environment.

Requirements

2-5 years of clinical research experience is desirable
Excellent verbal and written communication skills
High level of organization
Experience in project management
Proficiency in Microsoft Office (Word, Excel)
Bachelor's degree in related field
Willing and able to travel to other sites to ensure compliance
Attention to detail
The ability to manage multiple responsibilities simultaneously
Reasoning Ability
Ability to discern prioritization of tasks and actively manage ongoing responsibilities is crucial.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Thorough knowledge in computer information systems.

Responsibilities

Organize and maintain study documents
Oversee staff and site related documentation and certifications
Ensure regulatory compliance by all sites to ICH-GCP guidelines and site operational procedures
Prepare site for regulatory inspection
Submit continuing review reports
Submit new study IRB submissions
Travel to U.S. Urology Sites to review Regulatory
Work with Operational Support Specialist during study start-up to provide all necessary documentation for site activation
Attend meetings as required
Performs other duties as assigned