Oncology Research Regulatory Specialist

Avera Health•Omaha, NE

54d•$21 - $32

About The Position

Works under general direction to perform professional level clinical research assignments. Prepares and completes regulatory documents for protocols as requested by investigators, sub-investigators and clinical research coordinators. Submits all required research documents to the protocol sponsor, the Institutional Review Boards (IRB), the FDA, and any other regulatory agency as required by the research project.

Requirements

The individual must be able to work the hours specified.
To perform this job successfully, an individual must be able to perform each essential job function satisfactorily including having visual acuity adequate to perform position duties and the ability to communicate effectively with others, hear, understand and distinguish speech and other sounds.
These requirements and those listed above are representative of the knowledge, skills, and abilities required to perform the essential job functions.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions, as long as the accommodations do not cause undue hardship to the employer.
2 years regulatory, quality or data analyst

Nice To Haves

Bachelor's
1-3 years related research experience and/or training

Responsibilities

Prepares correspondence, informed consent, and regulatory specific documents for submission for study start up to sponsors, contract research organizations, and Institutional Review Boards as required by contracts, statutes, or regulations.
Provides regulatory tasks across the Avera Network.
Distributes and tracks training and delegated tasks required by the study to ensure compliance.
Critically reviews and updates study related documents to align with the protocol and site requirements.
Maintains or manages the electronic regulatory system and maintains regulatory documents on all clinical research studies.
Designs and maintains databases, spreadsheets, and other computer files used in the administration of research.
Actively assists in developing, coordinating, and participates in research specific meetings.
Submits all ongoing clinical research studies to the appropriate Institutional Review Board for annual re-approval.
Submits all adverse events and safety reports related to clinical research studies to the appropriate Institutional Review Board.
Ensures all ongoing clinical research study regulatory binders have up-to-date professional licenses or certificates.