Clinical Research Regulatory Specialist

LE0002 U.S. Urology Partners, LLC; New York (NY); Hybrid; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

HSA/FSA

401(k) matching

Employee Assistance Program

Job summary

U.S. Urology Partners is seeking a Clinical Research Regulatory Coordinator to maintain regulatory documents and ensure sites adhere to ICH-GCP and SOPs. Travel to U.S.

Urology sites for startup work and regulatory reviews will be involved. The role requires strong organizational skills and collaboration with cross-functional teams. The ideal candidate has 2–5 years of clinical research experience, excellent communication, and proficiency with Microsoft Office.

Qualifications

• 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 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.
• Computer Skills To perform this job successfully, an individual should have 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

Skills

Clinical research

Regulatory compliance

Documentation management

Communication

Project management

Microsoft Office

Travel willingness

Education

Bachelor's degree in related field

Tools

Word

Excel

Job description

U.S. Urology Partners is seeking a Clinical Research Regulatory Coordinator to maintain regulatory documents and ensure sites adhere to ICH-GCP and SOPs. Travel to U.S.

Urology sites for startup work and regulatory reviews will be involved. The role requires strong organizational skills and collaboration with cross-functional teams. The ideal candidate has 2–5 years of clinical research experience, excellent communication, and proficiency with Microsoft Office.