Clinical Research Data & Regulatory Coordinator

Mary Bird Perkins Cancer Center • Baton Rouge, LA

3d

About The Position

The Data and Regulatory Coordinator collaborates with the Clinical Research team and the Principal Investigator by knowledge of current protocol requirements; maintains IRB documents, regulatory and protocol documentation for assigned clinical trials administered by the Center which may include multi-site trials; facilitates communication and correspondence between Clinical Research and sponsoring agencies; collects protocol specific information from physicians, nurses, patients, family members, local caregivers, and others utilizing protocol specific methods; ensures that all designated Clinical Research regulatory and data management activities for all clinical research sites are executed in accordance with all applicable laws, regulations, policies and protocol requirements; performs additional duties as requested by supervisor and/or described in position description.

Requirements

• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline.
• Basic science degree, or certification or licensure in a health care field
• Demonstrated success in management of regulatory submissions activities.

Nice To Haves

• Medical or scientific research experience preferred.
• Professional Certifications preferred

Responsibilities

• Assures that the regulatory and data for trials being managed according to rules and guidelines governing the conduct of clinical research trials.
• Monitor/Auditor Preparation and Participation
• IRB Preparation and Presentation
• Protocol research document maintenance
• Policies & procedures
• Other duties and professional development

What This Job Offers

• Career Level: Mid Level