Director, Clinical Research - Regulatory Affairs

LCMC Health • Metairie, LA

2d • Onsite

About The Position

The Director of Clinical Research is responsible for the generation of key study documents and the oversight of clinical study conducted in collaboration with other departments within the organization. Leads the department and develops processes for clinical research to ensure optimal outputs. Ensures clinical research projects are allocated and distributed amongst teams. Determines clinical trial objectives, technology, systems, information specifications, schedules, funding, and staffing requirements. Collaborates with other departments to ensure the completion of clinical research studies. Oversees regulatory compliance of the IRB. Manages daily operations of Research Administration.

Requirements

• 3 years of experience in Administrative Services.
• 1 year of management experience in a university or other research setting.
• Bachelor's degree in Business, Healthcare Management Safety, or Science related field.

Responsibilities

• Administers the grant pre- and post-award process.
• Coordinates application process to ensure budgetary, regulatory, and contractual needs are met.
• Prepares subcontracts and other agreements as related to trials center.
• Maintains project records in accordance with the applicable laws and regulations.
• Administers the IRB, working with the senior management to ensure that protocols are reviewed in a timely and thorough manner.
• Works closely with the IRB regarding all matters of human subject’s research.
• Develops hospital/departmental policies and procedure manuals and regulations assuring compliance on research contracts, research funding systems and conflicts of interest related to sponsored research.

What This Job Offers

• Job Type: Full-time
• Career Level: Director