Regulatory Coordinator

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.

• 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

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.

Computer Skills To perform this job successfully, an individual should have thorough knowledge in computer information systems.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job is sedentary most of the time, with infrequent requirements to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl.

The employee may lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

This job operates in a professional office environment.

This role routinely involves standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

Duties, responsibilities and activities may change at any time with or without notice.

Travel includes out-of-the-area, and overnight travel is to be expected.

At U.S. Urology Partners, we are guided by four core values.

Every associate living the core values makes our company an amazing place to work.

Here Every Family Matters Compassion Make Someone's Day Collaboration Achieve Possibilities Together Respect Treat people with dignity Accountability Do the right thing

Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more.

U.S. Urology Partners is one of the nation’s largest independent providers of urology and related specialty services, including general urology, surgical procedures, advanced cancer treatment, and other ancillary services.

Through Central Ohio Urology Group, Associated Medical Professionals of NY, Urology of Indiana, and Florida Urology Center, the U.S. Urology Partners clinical network now consists of more than 50 offices throughout the East Coast and Midwest, including a state-of-the-art, urology-specific ambulatory surgery center that is one of the first in the country to offer robotic surgery.

U.S. Urology Partners was formed to support urology practices through an experienced team of…