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 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…