Description

Summary

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.

The Clinical research Project Manager is required to have an advanced knowledge of protocol requirements and good clinical practices as set forth by federal regulations. In addition, the Clinical research Project Manager will support the development of research projects including proposal applications, scientific study design, IRB protocols, budgets, contracts, personnel recruitment, hiring, and training, as well as reports on expenses, progress, and effort in collaboration with the Associate Director. The Clinical research Project Manager will work closely with superiors and executive-level management to define strategic goals for the Center as well as develop and implement operational plans in order to achieve said goals. Furthermore, the candidate will develop, oversee, and maintain relationships with Institutional Review Board, internal and external investigators, other personnel at external clinical sites, funding sponsors, vendors, and other key stakeholders.

Required Knowledge, Skills, and Abilities

• Working and in-depth knowledge of FDA, ICH GCP, and other regulatory compliance guidelines
• Working and in-depth knowledge of federal regulations and IRB procedures
• Working and in-depth knowledge of IRB submission process and requirements

• Excellent organizational, problem-solving, and leadership abilities

• Outstanding negotiation, communication and people skills

• In depth knowledge of diverse operations functions and principles (e.g., resource management, finance)

• Ability to maintain confidentiality in all work performed

• Ability to acquire and maintain all required CITI training certificates

• Ability to acquire and maintain credentialing at all required institutions including Tulane Medical Center, University Medical Center, Touro Infirmary, East Jefferson Hospital

• Proven track record of successful clinical trial management including history of overseeing clinical research studies that are completed on time, within budget, and to the satisfaction of stakeholders

Required Education and/or Experience

• Bachelor's Degree required
• At least three (3) years of management experience

Preferred Qualifications

• Preferred Masters's, Ph.D or M.D
• 5+ years of experience managing and training clinical research staff

• 5+ years of experience conducting cardiovascular research studies• Certification as a Certified Clinical Research Coordinator (CCRC through the Association of Clinical Research Professionals or ACRP) OR Certified Clinical Research Professional (CCRP through the Society of Clinical Research Associates or SoCRA) is strongly desired.

• Regulatory Affairs Certification (RAC), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or Certified IRB Professional (CIP) preferred

• Proven ability to plan and manage operational process for maximum efficiency and productivity

• Outstanding organizational, negotiation, communication, and leadership, and people skills demonstrated by previous professional success

• Proven ability to develop innovative solutions for increased productivity