Research Regulatory Coordinator

United Urology Group•Lakewood, CO

9d•Onsite

About The Position

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.

Requirements

High School Diploma Required.
Two (2) years minimum of directly related experience, or equivalent combination of education and experience.
Current GCP Certification.
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.

Nice To Haves

AA/AS or BA/BS degree preferred (or equivalent combination of experience and education).
ACRP/SOCRA (or equivalent) certification preferred.

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.