Research Regulatory Specialist Senior

LCMC Health•New Orleans, LA

3d•Onsite

About The Position

The Research Regulatory Specialist Senior is responsible for providing support for implementation of clinical trials. Performs a wide variety of start-up activities integral to the successful application and acceptance of essential regulatory documents for clinical research protocols. Responsible for ensuring submission of documents to pharmaceutical sponsors, Institutional Review Board (IRB), and contract research organizations (CRO) as applicable. Serves as a liaison between the various sponsors, IRB, and internal departments/staff in order to implement clinical trials and research projects with minimal protocol deviations. Assists and guides new and junior team members.

Requirements

5 years of experience in clinical research.
Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments (i.e., Word, Excel, Internet).
Ability to communicate quickly and effectively with the Institutional Review Board is required.

Nice To Haves

Previous experience as a regulatory coordinator for industry or non-industry clinical trials.
Associate’s Degree (7 years of experience in research will be considered in lieu of education).
Bachelor's Degree.

Responsibilities

Manages study regulatory documents such as limited FDA Form 1572, Protocol Amendments, safety reports, site delegation signature logs, etc.
Completes all regulatory documents needed in preparation for submission to the pharmaceutical sponsor and/or CRO.
Completes all documents needed in preparation for submission to the IRB. These include submission letters, questionnaires, generic advertisements, etc.
Regularly and as needed, meets with the appropriate leader to discuss new studies and the updating of current studies.
Assists with site visits and prepares for audits as needed.
Prepares monthly IRB summaries for current studies and prepares weekly summary of tasks reports and regulatory status reports.
Manages and updates all nursing and medical licenses on file for investigators, research coordinators, and other staff.
Assists with completion of data reporting as needed.
Submits monthly study financial reports.
Participates in internal quality assurance activities.
Reviews clinical data provided by physicians and nurses, checking for consistency and accuracy.
Responsible for correcting errors.
Coordinates audits for assigned protocols.
Mentors junior staff and assists the clinical team in the development of trial specific training tools for the study staff.