Project Manager II, Clinical Research

Tulane University • New Orleans, LA

80d

About The Position

The Clinical research Project Manager is responsible for the management of all aspects of clinical trial conduct at the TRIAD Center including regulatory compliance, patient safety, data quality and personnel management. The ideal candidate will have proven senior management experience with excellent organizational, communication, and leadership skills. Under the direction of the Center Director and Associate Director, this person will be independently manage, coordinate, and provide oversight of clinical research study conduct across multiple research studies and trials at multiple clinical sites. In addition, this person will serve in a key management and administrative role for all clinical research projects conducted at the TRIAD Center through the management of the clinical research team and ensuring compliance with established protocols, study timelines as well as institutional, local, and federal requirements.

Requirements

• Advanced knowledge of protocol requirements and good clinical practices.
• In-depth knowledge of FDA, ICH GCP, and other regulatory compliance guidelines.
• Working knowledge of federal regulations and IRB procedures.
• Proven track record of successful clinical trial management.
• Bachelor's Degree required.
• At least three (3) years of management experience.
• 5+ years of experience managing and training clinical research staff.
• 5+ years of experience conducting cardiovascular research studies.

Nice To Haves

• Master's, Ph.D or M.D preferred.
• Certification as a Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) is strongly desired.
• Regulatory Affairs Certification (RAC) or Certified IRB Professional (CIP) preferred.

Responsibilities

• Manage all aspects of clinical trial conduct at the TRIAD Center.
• Ensure regulatory compliance, patient safety, and data quality.
• Oversee personnel management and coordinate clinical research study conduct.
• Support the development of research projects including proposal applications and scientific study design.
• Manage IRB protocols, budgets, contracts, and personnel recruitment.
• Report on expenses, progress, and effort in collaboration with the Associate Director.
• Define strategic goals for the Center and develop operational plans.
• Maintain relationships with Institutional Review Board, investigators, funding sponsors, and other stakeholders.

What This Job Offers

• Career Level: Senior
• Industry: Educational Services
• Education Level: Bachelor's degree