Research Regulatory Coordinator

Location:

3901 Parkway Circle, Suite 100, Springdale, AR, 72762, United States

Job Category: research, clinical, regulatory

Employee Type:
Non Exempt - Full Time

Manage Others:
No

Contact:
Brittany Weathers,

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.

• 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.

• 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.
• Attends research department meetings when held.

• Maintains patient/sponsor confidentiality.
• Promptly reports to work at designated times.
• Maintains good attendance with no unexcused absences.
• 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.
• Attends required meetings/activities.

• Maintains organized files and office space.
• Effectively sets priorities.
• Demonstrates flexibility in schedule to accommodate workload.
• Submits routine reports on or before due date.
• Maintains at‑a‑glance protocol information in office.

• Demonstrates professionalism in appearance/dress code consistent with policy of HOG.
• Seeks to increase skills through self‑directed learning activities.
• Demonstrates initiative in seeking new projects and making corporate‑related contributions.
• Willing to take continuing education courses as appropriate.
• Recognizes personal/professional limitations and strives for improvements.
• Acts as team member both corporately and within the individual setting.
• After achieving two years of research experience, it is preferred to test and pass the certification for Certified Clinical Research Professional (CCRP).

• High school graduate or higher
• Healthcare experience required and clinical research experience
• Knowledge of medical records
• Experience with electronic medical records
• After…