Research Regulatory Assistant

BHS•Indianapolis, IN

8d•Remote

About The Position

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 Baptist Office of Research Administration. Provides administrative support for the maintenance and data entry of the research regulatory and compliance specialists. Performs a variety of duties and responsibilities as well as project assignments. If you would like to be part of a growing family focused on supporting clinical excellence, teamwork and innovation, we urge you to apply now! Baptist Health is an Equal Employment Opportunity employer. Founded in 1924 in Louisville, Kentucky, Baptist Health is a full-spectrum health system dedicated to improving the health of the communities it serves. The Baptist Health family consists of 10 hospitals, employed and independent physicians, and more than 470 points of care, including outpatient facilities, physician practices and services, urgent care clinics, outpatient diagnostic and surgery centers, home care, fitness centers, and occupational medicine and physical therapy clinics. Baptist Health’s eight owned hospitals include more than 2,300 licensed beds in Corbin, Elizabethtown, La Grange, Lexington, Louisville, Paducah, Richmond and New Albany, Indiana. Baptist Health also operates two joint venture hospitals: the 410-bed Baptist Health Deaconess Madisonville in Madisonville, Kentucky with Deaconess Health System based in Evansville, Indiana, and the Baptist Health Rehabilitation Hospital, a 40-bed inpatient rehabilitation facility with Encompass Health, based in Birmingham, Alabama. Baptist Health employs more than 24,000 people in Kentucky and surrounding states. Baptist Health is the first health system in the U.S. to have all of its hospitals recognized by the American Nursing Credentialing Center with either a Magnet® or Pathway to Excellence® designation for nursing excellence. Baptist Health’s employed provider network, Baptist Health Medical Group, has more than 1,820 employed providers offering care in 78 specialties, including approximately 862 physicians and 958 advanced practice clinicians. Baptist Health’s physician network also includes more than 2,000 independent physicians. EEO Statement: Baptist Health is an Equal Employment Opportunity employer, and seeks to employ individuals without regard to race, color, national origin, gender, sexual orientation, gender identity, age, disability, marital status, citizenship status, military status, religious or political beliefs, protected veteran status, employment status or any other protected class identified in any federal, state, or local law. Baptist Health specifically encourages minority, female, disabled, veteran and other candidates from diverse backgrounds to apply and strengthen our team. Please note that Baptist Health is a drug-free workplace and employment with Baptist Health is subject to post offer, pre-employment drug testing. NOTICE OF NONDISCRIMINATION AND ACCESSIBILITY TO SERVICES Persons with hearing and speech impairments can contact Baptist Health facilities by using the Kentucky Relay Service, a toll-free telecommunication device for the deaf (TDD). For voice to TDD, call 800.648.6057. For TDD to voice, call 800.648.6056.

Requirements

High School/GED
Must be proficient with computer software applications, web-based platforms, portals, Microsoft office products, office equipment such as copiers, high-volume scanners, electronic document storage, and other administrative tasks
40 Hour work week; 8:00am-4:30pm
Residency in KY or IN

Nice To Haves

Administrative experience preferred.
Business and/or healthcare terminology fluency preferred.

Responsibilities

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