Regulatory Coordinator

Socket.dev; Tennessee; Hybrid; USD 55,000 - 85,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Employee Assistance Program (EAP)

Job summary

U.S. Urology Partners is seeking a Clinical Research Regulatory Coordinator to maintain regulatory documents and ensure sites adhere to ICH-GCP guidelines. The role involves coordinating submissions, inspections, and staff certifications while working with clinical research teams in a dynamic setting.

The ideal candidate will be highly organized, possess excellent communication skills, and be willing to travel to U.S. urology sites to review regulatory activities.

Qualifications

• Bachelor's degree in a related field is required.
• Excellent written and spoken communication.
• Strong organization and multitasking abilities.
• Experience in clinical research project management.
• Willingness to travel to other sites to ensure compliance.

Responsibilities

• Organize and maintain study documents
• Oversee staff and site 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
• Collaborate 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

Excellent verbal and written comm.

High level of organization

Experience in project management

Microsoft Office (Word, Excel)

Willingness to travel

Education

Bachelor's degree in related field

Tools

Microsoft Office

Job description

Clinical Research Regulatory Coordinator

About the Role

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.

What You'll Be Doing

• 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 OperationalSupport Specialist during study start-up to provide all necessary documentationfor site activation
• Attend meetings as required
• Performs other duties as assigned

What We Expect From You

• 2-5 years of clinical research experienceis 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.

Physical Demands

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.

Work Environment

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.

Other Duties

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

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

What We are Offer You

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.

About US Urology Partners

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 healthcare executives and resources, while serving as a platform upon which NMS Capital is building a leading provider of urological services through an acquisition strategy.

Salary Range: Please note that the hourly range for this position will vary based on experience level, education and geographical location.

$0.00 - $0.00 / hour

U.S. Urology Partners is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.