Research Regulatory Coordinator

Astera Cancer Care; Lakewood (CO); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Tuition reimbursement

Health, dental, and vision insurance

Corporate discounts

Job summary

United Urology Group is seeking a Clinical Research Regulatory Coordinator to support research teams by managing study start-up, regulatory compliance, and document control for human subjects trials. You will ensure regulatory files are accurate, current, and accessible, serving as the central regulatory resource under the Director of Clinical Research.

The role requires knowledge of FDA/ICH guidelines, GCP certification, and strong organizational skills to balance multiple studies, timelines,

Qualifications

• Two years minimum of directly related experience, or equivalent combination of education and experience.
• ACRP/SOCRA (or equivalent) certification preferred.
• Current GCP Certification.

Responsibilities

• Submit regulatory documents to IRB/IBC and sponsors in a timely, accurate manner.
• Maintain staff credentials including CVs, licenses and disclosure forms.
• Serve as primary IRB/IBC contact and coordinate regulatory submissions.
• Track protocol approvals through IRB/IBC/subcommittee processes and improve turnaround times.
• Ensure compliance with current federal, state, and local regulations and SOPs.

Skills

FDA/NIH/OHRP regulations

GCP knowledge

Communication skills

Attention to detail

Documentation

Education

High School Diploma

AA/AS or BA/BS degree

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Publisher

EDC Systems familiarity

Job description

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!

Job Description

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.

Responsibilities

• 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.
• Understands current regulatory requirements and ensures a smooth submission process to minimize delays to study initiation.
• Works with multiple IRBs and understands their submission process and requirements.
• Works with multiple IBCs and assist with setting up new IBC Committee’s and understands their submission process and requirements.
• New study submissions to the regulatory authorities, IRB, IBC and sponsors including initial submissions, amendments, safety reports, deviations, etc. to ensure timely, accurate submissions.
• Maintains staff credentials including the CV, licenses, Financial Disclosure Forms (FDF), etc.
• Serves as primary IRB & IBC contact & provides institutional authorization for new submissions.
• Tracks each protocol through the IRB/IBC/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease the delay in the approval process.
• 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.
• Will produce, as applicable, and maintain regulatory binders prior to studies starting with all required documents and ensure dedicated electronic study folder is current.
• Obtains and completes all required documents for new submissions, exemption requests, compassionate uses, amendment applications, continuing review, and closure activities.
• Reviews informed consents for institutional language additions.
• Remains informed of current federal, state, and local regulations regarding clinical research and communicates any changes to the study team.
• Maintains working knowledge of current protocols and internal Standard Operating Procedures (SOP).
• Participates in required teleconferences, on-site meetings, and off-site investigator meetings, as required.
• Documents and tracks research training of investigators and research staff.
• Additional responsibilities as assigned to help drive our mission.

Required or Preferred Qualifications

• High School Diploma Required.
• AA/AS or BA/BS degree preferred (or equivalent combination of experience and education).
• ACRP/SOCRA (or equivalent) certification preferred.
• Two (2) years minimum of directly related experience, or equivalent combination of education and experience.
• Current GCP Certification.

Key Competencies

• Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines.
• Excellent communication skills and superb attention to detail.
• Excellent interpersonal skills and customer service focus is required.
• Strong writing and organizational skills.
• Able to work in a fast-paced environment with flexibility and autonomy.
• Must be able to prioritize tasks on a daily basis.
• Computer knowledge in Microsoft Windows applications (including Word, Outlook, Excel, PowerPoint, Publisher), Clinical Trial Master Systems and familiarity with Electronic Data Capture Systems.
• Attendance is an essential job function.

Physical Requirements

Large percent of time spent performing computer-based and paper based work is required. 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 lift and carry items weighing up to 25 lbs.

Job Type

Full-Time

Compensation

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.

About the Company

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