Clinical Research Data & Regulatory Coordinator

About the Organization

Mary Bird Perkins Cancer Center is Louisiana’s leading cancer care organization, caring for more patients each year than any other facility in the region. With strategic hospital and physician partnerships, we deliver state-of-the-art treatments and unparalleled collaborative, comprehensive cancer services. This culture of innovation attracts expert physicians, highly specialized scientists, and forward-thinking leaders in supportive care and other disciplines. Together with our partners, we are 100% focused on cancer care.

About the Role

This is a 100% in-person position. The Data and Regulatory Coordinator collaborates with the Clinical Research team and the Principal Investigator by maintaining knowledge of current protocol requirements. The role involves managing IRB documents, regulatory and protocol documentation for assigned clinical trials (including multi-site trials), facilitating communication between Clinical Research and sponsoring agencies, and collecting protocol-specific information from physicians, nurses, patients, and caregivers. The coordinator ensures all regulatory and data management activities comply with applicable laws, regulations, policies, and protocol requirements.

Responsibilities

• Demonstrate knowledge and understanding of the evolution of clinical research.
• Participate in clinical research studies by ensuring regulatory and data compliance for trials according to governing rules and guidelines.
• Prepare for and participate in monitor/auditor activities.
• Handle IRB preparation and presentation.
• Maintain protocol research documents.
• Develop and adhere to policies and procedures.
• Perform additional duties as requested by supervisor or as described in the position description.
• Engage in professional development activities.

Requirements

• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline.
• Basic science degree, or certification/licensure in a healthcare field.
• Demonstrated success in managing regulatory submissions activities.
• Medical or scientific research experience preferred.
• Professional certifications preferred.