Research Regulatory Coordinator

Responsibilities

• Performs all study-start-up activities – initial IRB Submission, initial FDA Form 1572, initial Financial Disclosure Forms, request study access for assigned coordinator and data manager
• Prepares/maintains protocol files accurately and in a timely fashion
• Insures most recent protocols, amendments, and memos are on file in the respective offices and on the Research drive
• Maintains accurate and complete sponsor correspondence files in the regulatory binders
• Provides support to the data managers and coordinators as requested
• Coordinates and attends sponsor site initiation visits at office
• Acts as a contact for all regulatory concerns
• Submits protocol/ICF changes to the IRB in a timely manner
• Maintains accurate and complete IRB correspondence files and follow-up actions
• Insures the most recently approved versions of the ICF are available at each site and on the Research drive
• Notifies Clinical Research Coordinator of consent form and protocol changes when necessary
• Submits site related Serious Adverse Events
• Submits site related protocol deviations, if applicable
• Answers the research department phone
• Escort Clinical Research Associates from the front lobbies
• Provide tours when needed
• Scans source documents into HOG drives and EMR when applicable
• Posts and tracks training of all new trial materials on SharePoint
• Scans staff training certificates into the appropriate folders, when needed

Preferred

• After achieving two years of research experience, it is preferred to test and pass the certification for Certified Clinical Research Professional (CCRP)

Benefits

• Certified as a Great Place to Work
• For more than three decades, Highlands Oncology has been at the forefront of advancing cancer care in Northwest Arkansas.
• Springdale, Arkansas, USA
• https://highlandsoncology.com
• Late Stage
• Leadership Team
• Jeff Hunnicutt
• Chief Executive Officer
• Mike Gebhart
• Chief Financial Officer
• Recent News
• Talk Business & Politics
• Construction starts on 7th Highlands Oncology Center
• 2026-06-22
• Jeff Hunnicutt to step down as CEO of Highlands Oncology
• 2026-06-19
• Highlands Oncology opens $4 million clinical trials suite
• 2026-06-03
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Qualifications

• Demonstrates a high level of professionalism and responsiveness when interacting with internal and external customers
• Advises supervisor or other appropriate individuals of problems or concerns
• Utilizes appropriate channels of communication in accordance with organizational structure
• Collaborates effectively with physicians, nurses, and ancillary departments
• Acts as liaison between PI, sponsor, patient, Clinical Research Coordinator, Research Data Manager, and IRB
• Communicates routinely with supervisor/liaison regarding start up status
• Demonstrates effective oral and written communication skills
• Maintains patient/sponsor confidentiality
• Follows up on issues as appropriate
• Supports and adheres to organizational decisions, policies, and procedures
• Willingly accepts assignments and completes them in a timely manner
• Maintains organized files and office space
• Effectively sets priorities
• Submits routine reports on or before due date
• High school graduate or higher
• Healthcare experience required and clinical research experience
• Knowledge of medical
• Experience with electronic medical
• Must complete registration with NCI me
• After achieving two years of research experience, it is preferred to test and pass the certification for Certified Clinical Research Professional (CCRP)

Required skills

• Healthcare Experience

Experience

• Mid level