Regulatory Research Specialist

2 days ago

Baton Rouge, Louisiana, United States FMOLHS Full time
Description

This is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, efforts, or working conditions associated with the job. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e g., emergencies, changes in personnel, workload, rush jobs, or technological development).

#CB

Responsibilities

1.   Program Management
a.   Assures contracts are consistent with regulatory document language.
b.   Develops protocol templates in electronic research software to assure accurate revenue capture.
c.   Serves as a liaison for communicating the need for the appropriate priority to be given to the regulatory compliance process and that the practices of the organization are congruent with all regulatory agencies.
d.   Follows client's progress through the research trial and provides documentation to IRB within appropriate time periods.
e.   Manages the overall regulatory functions of all research studies within the Department of Academic Affairs.
f.   Maintains regulatory documentation for all clinical research studies managed within the Clinical Research Department.

2.   Quality
a.   Utilizes all equipment, supplies, facilities, and resources in a prudent and efficient manner in order to ensure efficient departmental operations and the provision of high quality health care services
b.   Promotes the quality and efficiency of his/her own performance by remaining current with the latest trends in field of expertise through participation in job-relevant seminars and workshops, attendance at professional conferences, and affiliations with national and state professional organizations.
c.   Ensures compliance with applicable regulatory agency and Joint Commission standards and ensures that all services provided by the department are performed with compassion, understanding, and respect for others.

3.   Collaboration and Partnership
a.   Manages relationships with study sponsors, investigators, and associated staff to provide the highest level of customer service.
b.   Works collaboratively with internal and external customers to maintain electronic research software.
c.   Educates research staff regarding accurate data capture.
d.   Alerts research administration related to regulatory compliance issues that may be problematic for OLOL structures.

4.   Other Duties As Assigned
a.   Performs other duties as assigned or requested.
 

Qualifications

Experience
3 years experience in healthcare or research.

Education
Bachelor degree

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