Specialist Regulatory Affairs CRI Personnel

SEH Saint Elizabeth Medical Center•Edgewood, KY

1d•Onsite

About The Position

The Specialist – Regulatory Affairs will apply a comprehensive understanding of research regulations, ethics and guidelines, and analyze research IRB submissions to determine compliance with regulation. Oversee the review and correspondence of research regulatory data. Use independent judgment to interpret, analyze, and apply federal, state, and SEH policies to promote ethical practices in research involving human subjects and to ensure compliance to those regulations by faculty and staff investigators. Act as a liaison between IRB and research team to promote information flow. Ensure study documentation remains in compliance with study protocols. Demonstrate respect, dignity, kindness and empathy in each encounter with all patients, families, visitors and other employees regardless of cultural background.

Requirements

Bachelor’s Degree in related area of study.
Understanding of research processes
Ability to effectively manage and prioritize multiple tasks while meeting tight deadlines.
Proficiency with Excel, Word, Outlook and PowerPoint is imperative.
Ability to work effectively and in a professional manner with physicians, leadership, SEH/SEP associates, patients, external business partners, representatives of regulatory agencies and the general public.
3 year’s related experience in specialty area.

Responsibilities

Prepare, review, and execute regulatory submissions to the IRB and other regulatory authorities for the CRI.
Serve as a regulatory contact and provide regulatory-related study updates to CRI staff, physicians and physicians.
Oversee CRI study start-up from the regulatory standpoint to ensure that site meet Sponsors, IRB, and other regulatory authority’s requirements.
Manage the maintenance of the site certifications (CLIA, DEA, etc. and all Sub-I / PI staff credentials (CV, medical license, DEA form, etc).
Be the liaison with the sponsoring agency for regulatory approvals throughout the life of the study.
Disseminate regulatory information and participate in training.
Provide guidance and serve as a resource to co-workers.
Supply direction and feedback to research team to ensure awareness of business practices and quality standards.
Participate in internal and external audits, and regulatory authority inspections.
Customer Service – Align with the mission, vision, and values of SEH.
Communication – Demonstrate clear, diplomatic, effective oral and written communication and exhibit initiative, effort, resourcefulness, and professional demeanor in a timely manner.
Attend research team meetings to provide updates and report regulatory issues.
Develop and maintain the regulatory and essential documents to be in compliance with Standard Operating Procedures (SOP) and Practice Guidelines (PG).
Performs other duties as assigned.