Regulatory Coordinator

LE0002 U.S. Urology Partners, LLC; New York (NY); Hybrid; USD 85.000 - 115.000; Vollzeit

Benefits dieser Stelle

Medical benefits

Dental benefits

Vision benefits

HSA/FSA

401(k) matching

Employee Assistance Program

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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

Kenntnisse

Clinical research

Regulatory compliance

Documentation management

Communication

Project management

Microsoft Office

Travel willingness

Ausbildung

Bachelor's degree in related field

Tools

Word

Excel

Jobbeschreibung

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 Operational Support Specialist during study start-up to provide all necessary documentation for site activation
• Attend meetings as required
• Performs other duties as assigned

What We Expect From You

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.

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.

Our Growth is Creating Great Opportunities! Our team is expanding, and we want to hire the most talented people we can. Continued success depends on it!

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.

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.

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.