What are the responsibilities and job description for the Research Regulatory Coordinator position at Highlands Oncology Group?
Join a world class team and help to bring cancer treatment HOME!
Highlands Oncology began in 1996 with three physicians and a desire to change the face of oncology care in our community. Dr. Malcolm Hayward, Dr. Dan Bradford, and Dr. Thad Beck knew that patients do better at home, in the community where they live and work, and where their support system is already in place. In furthering that goal, Highlands has grown with the region from a single location 26 years ago, to 6 locations in Northwest and Northcentral Arkansas today employing more than 750 diverse team members.
As Northwest Arkansas continues to grow, so must the services and providers available in the region. Highlands Oncology is committed to remaining on the cutting edge to ensure our community has access to the very best cancer care. What we have is something quite unique right here in our own backyard with a caring multidisciplinary team focused on treating patients like family.
Job Summary: The Research Regulatory Coordinator is responsible for regulatory documentation and compliance for clinical trials, consistent with good clinical practice guidelines, the Highlands Oncology Group policies and procedures, and sponsor requirements within the assigned setting.
Job Duties / Responsibilities:
Protocol Management
- 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.
IRB Responsibility
- 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.
Miscellaneous
- 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.
