Research Regulatory Assistant

Summary

Job Description:

Baptist Health is looking for a Research Regulatory Assistant to join their team. This is a remote work position that requires residency in KY or IN

Provides direct administrative support for the research regulatory team, and ancillary support for BaptistOffice of Research Administration. Provides administrative support for the maintenance and data entry ofthe research regulatory and compliance specialists. Performs a variety of duties and responsibilities as wellas project assignments.

Essential Duties:

• Provides administrative support for research regulatory and compliance staff.

• Provides document development, copying, assembling, filing, and mailing as required.

• Prepares regulatory documentation for scheduled study sponsor monitoring visits and audits. (Includes both paper and electronic file preparation.)

• Assist regulatory specialists to resolve outstanding action items from internal or external monitoring visits

• Maintains research web site information and active studies lists to ensure accuracy and disseminates appropriately to research staff.

• Assists in the maintenance of regulatory files to ensure audit-ready state

• In consultation with research regulatory specialist - prepares and submits continuing renewal applications to IRB of record for active clinical research trials

• Assists with scanning and filing regulatory documentation into electronic regulatory binder system.

• Assist with the development of staff/provider research training materials

• Manage compilation, distribution, and acknowledgement of Safety/SUSAR reports per Baptist Health process to ensure compliance

• Create operational review forms according to study start-up timelines

Qualifications:

• High School/GED

• Administrative experience preferred.

• Business and/or healthcare terminology fluency preferred.

• Must be proficient with computer software applications, web-based platforms, portals, Microsoft office products, officeequipment such as copiers, high-volume scanners, electronic document storage, and other administrative tasks

40 Hour work week; 8:00am-4:30pm

Work Experience

Education