Description

Are you interested in making a difference in patient care? Learn about our unique culture of respect, growth, innovation, the best patient care, and how we give back to the community.

At United Urology Group, our employees are at the heart of our mission and have incredible opportunities to impact our patients' lives with their urologic care.

• We foster a culture that thrives on compassion, teamwork, integrity, and diversity, all of which start with our staff!
• We deliver a cohesive approach to urologic care that provides patients with access to experienced specialists, a superb team of healthcare professionals, and the most advanced technology for patient treatments and therapies.
• We offer competitive salaries and a great work/life balance: enjoy your weekends!
• UUG offers outstanding benefits, including tuition reimbursement, health, dental, and vision insurance, corporate discounts, and much more!

United Urology Group is regarded as the leading urology network in the country. Our Urology Group Affiliates consist of Chesapeake Urology, Arizona Urology- Phoenix & Scottsdale, Arizona Urology Tucson, Colorado Urology & Tennessee Urology.

Position Summary:

The Regulatory and Research Assistant plays a dual role, providing administrative support to both the Regulatory Manager and Clinical Research Coordinator. This position involves advancing medical research by ensuring regulatory compliance. Working closely with the Clinical Research Coordinator, the assistant aids in specimen and data collection and processing. Additionally, responsibilities include navigating regulatory frameworks, ensuring guideline adherence, managing documentation, and facilitating communication with regulatory authorities and the site.

Primary Duties & Responsibilities:

Regulatory Assistant

• Pre-populates site information on IRB submissions.
• Assists in completion of the Iron Mountain Record Storage Process.
• Obtains and files required documentation in the Central closeout binder.
• Updates master clinical trial information list, as directed.
• Send out yearly CURA FDFs to all Investigators and follow up for completion.
• Assists in maintaining and updating staff training logs, ensuring updated CVs, MLs, and CURA training are current.
• Sends out Sponsor requested updated training, signature pages, etc.
• Printing/Scanning and filing documents for regulatory binders or uploading documents in CTMS.
• Appropriately files IRB correspondence.
• Updates documents (1572, FDF, DOA & training), as directed, with staff changes.
• Updates pipeline trials log.
• Collects Sponsor/CRO site confirmation and follow-up letters.
• Set up new user accounts in CTMS.
• Assist with Internal Audit and or monitoring administratively, as requested.

Research Assistant

• Sets up, operates, and maintains various scientific apparatus.
• Work under specific instructions to assist the research coordinator with the execution of clinical research protocols.
• Create/Update Source Documents.
• Enter data from forms/sources and documents into the Sponsor database/eCRF/CTMS.
• Updates trial-related logs as directed by the coordinator.
• Prepares subject source charts in preparation for clinical trial visits.
• Collects and Processes Laboratory Specimens required per Protocol.
• Performs assigned clinical assessments such as, but not limited to, EKG tracing, Vital Assessments, PVR, and Uroflow measurements, as delegated on the DOA log.
• Schedules research subjects for protocol-required testing under the guidance of the research coordinator.
• Receives daily shipments and stocks/restocks needed clinical trial supplies except for Investigational Products.
• Responsible for ensuring study supplies are within the expiration date.
• Works with the coordinator to complete chart reviews, data mining, and mailing trial-related information to potential study subjects.
• Completes required site and sponsor-related training.
• Follow SOPs/GCPs/HIPPA according to the site, sponsor, and FDA.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.

Qualifications

Qualifications:

• Minimum High School Diploma or GED required.
• Minimum of five (5) years in an administrative role.
• Minimum of one (1) year clinical research experience.

Knowledge, Competencies & Skills:

• Proficient knowledge of Medical Terminology.
• Preferred understanding of FDA clinical trial phases I-IV.
• Preferred understanding of GCP, ICH Guidelines, and FDA regulations.
• Demonstrated ability to work independently and as an effective team member.
• Flexible hours and ability to travel to sites.
• Excellent customer service skills.
• Strong written and verbal communication skills.
• Proficient computer software and database skills.
• Strong attention to detail and ability to stay organized.
• Proven organizational skills and ability to prioritize effectively.
• Ability to multi-task, effectively problem-solve, and work in a fast-paced environment.
• Ability to type a minimum of 40 words per minute.

Direct Reports:

• N/A.

Travel:

• Must have the ability & willingness to travel to other sites as necessary within a geographic region.

Physical Requirements for the Job:

• Regularly required to sit and stand for extended periods.
• Involves standing, sitting, walking, bending, stooping, and twisting.
• Requires full range of body motion, including manual and finger dexterity and eye-hand coordination.
• Occasionally lifts and carries items weighing up to 25 lbs.

Equal Opportunity Employer: United Urology Group and its affiliate practices are an equal opportunity employer. We do not discriminate based on race, color, religion, age, sex, national origin, disability, veteran status, or sexual orientation.

The successful candidate(s) for any UUG position will be subject to a pre-employment background check.

Actual compensation offered to candidates is based on work experience, education, and/or skill level.