Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Regulatory Coordinator role.
Rezi rewrites your resume against U.S. Urology Partners's job description. Free.
Tailor your resume to this Regulatory Coordinator role.
Rezi rewrites your resume against U.S. Urology Partners's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Regulatory Coordinator posting at U.S. Urology Partners — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Regulatory Coordinator posting at U.S. Urology Partners — free, in seconds.
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 CRRC 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.
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
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)
- 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
- 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
Skills
- Clinical research
- Teamwork
- Maintaining regulatory documents
- ICH-GCP guidelines
- Site operating procedures
- Staff documentation
- Site-specific certifications
- Effective communication
- Collaboration with external vendors
- Dynamic work environment
- Project management
- Microsoft Office (Word, Excel)
- Computer information systems
Work Type
- Full-time
Experience Level
- 2-5 years of clinical research experience
Education Level
- Bachelor's degree in related field
Salary/Compensations
- $0.00 - $0.00 / hour
Benefits
- Comprehensive medical, dental and vision plans
- HSA / FSA
- 401(k) matching
- Employee Assistance Program (EAP)
About the Company
- 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.
Equal Opportunity
- 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.