Why Join Us?
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!
The Clinical Research Regulatory Coordinator will support clinical research teams (research physicians, research nurses, research coordinators etc.) in research efforts by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.
They will be responsible for ensuring that all research studies are compliant with regulations as well as maintaining accurate and up-to-date regulatory files. They will serve as a central regulatory resource for staff conducting clinical research. This position reports to the Director of Clinical Research.
Works closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to the Institutional Review Boards (IRB), Institutional Biologic Committees (IBC) and sponsors.
New study submissions to the regulatory authorities, IRB, IBC and sponsors including initial submissions, amendments, safety reports, deviations, etc. to ensure timely, accurate submissions.
Works with sponsors to ensure all proper regulatory documents are approved and that all documents, access to Case Report Form’s (CRF) and databases, study required portals, monitoring/auditing requirements have been completed prior to the start of a study.
Obtains and completes all required documents for new submissions, exemption requests, compassionate uses, amendment applications, continuing review, and closure activities.
Participates in required teleconferences, on-site meetings, and off-site investigator meetings, as required.
Computer knowledge in Microsoft Windows applications (including Word, Outlook, Excel, PowerPoint, Publisher), Clinical Trial Master Systems and familiarity with Electronic Data Capture Systems.
Involves standing, sitting, walking, bending, stooping, and twisting.
Job Type: Full-Time
Actual compensation offered to candidates is based on work experience, education, skill level, and geographic location. Compensation may vary depending on the state or region in which the position is located, in accordance with applicable laws.
This position has no close date. Applications will be accepted until an offer has been extended
and accepted.
Equal Opportunity Employer: Our Practice is 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.
