Research Regulatory Coordinator

United Urology Group; Lakewood (WA); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Tuition reimbursement

Health Insurance

Dental Insurance

Vision Insurance

Corporate discounts

Work-life balance

Job summary

United Urology Group in Lakewood, WA is seeking a Clinical Research Regulatory Coordinator to support study start-up and ensure regulatory compliance throughout trials involving human subjects.

You will manage IRB/IBC submissions, maintain regulatory binders, and serve as a primary regulatory resource for the research staff, working under the Director of Clinical Research to keep trials on schedule and compliant with FDA, NIH, OHRP, and ICH GCP guidelines.

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.

Responsibilities

• Facilitate IRB/IBC submissions and regulatory approvals.
• Maintain regulatory files and trial documentation.
• Serve as primary IRB/IBC contact and sponsor liaison.
• Ensure compliance with FDA, NIH, OHRP and ICH GCP guidelines.
• Coordinate study start-up activities and ongoing regulatory tasks.

Skills

FDA/ICH GCP

Regulatory submissions

Communication

Attention to detail

Documentation

MS Office

EDC systems

Education

AA/AS or BA/BS degree preferred

GCP Certification

Tools

Microsoft Word

Microsoft Excel

PowerPoint

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.

Theywill be responsible for ensuring that all research studies are compliant with regulations as well asmaintainingaccurate and up-to-date regulatory files.Theywill serve as a central regulatory resource for staff conducting clinical research. This position reports to the Director ofClinical Research.

Responsibilities:

• Works closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to theInstitutional 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 settingup new IBC Committee’sand understands their submission process and requirements.

• New study submissions to the regulatory authorities, IRB,IBCand 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& IBCcontact & 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 toCase 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 languageadditions.

• Remains informed of current federal, state, and local regulations regarding clinical research and communicates anychanges to the study team.

• Maintains working knowledge of current protocols and internalStandard 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.

Requiredor PreferredQualifications:

• 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.

KeyCompetencies:

• 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 oftime spentperforming computer-basedand paperbasedwork 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 andcarryitems weighing up to25lbs.

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.