Clinical Research Quality Assurance Specialist

Responsibilities

• Coordinate activities within the Quality Assurance Program for the Clinical Research Unit.
• Perform extensive quality assurance review of study documents and data across multiple complex studies of different therapeutic areas and phases and report findings to management and research team.
• Assist the Quality Program Manager in regard to specific departmental activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures. Establish and implement process improvement projects.
• Ensures that clinical trials are initiated, documented and reported in compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations.
• Create and maintain an education and training program for the Clinical Trial Unit.
• Performs other duties as assigned.
• Complies with all policies and standards.

• Bachelor’s Degree or 10 years of either clinical research experience or quality assurance experience or combination of both (Required)
• Master’s Degree (Preferred)
• 5+ years of either quality assurance or quality control experience or clinical research experience or combination of both; (Required)
• 3+ years of clinical research management experience including sound knowledge of US regulatory requirements for clinical research including FDA, ICH/GCP (Required)
• Outstanding organizational skills, oral and written communication skills and strong attention to detail. (Required proficiency)
• Strong interpersonal skills and ability to work as an effective team leader. (Required proficiency)
• Sound knowledge of state and federal regulatory guidelines. (Required proficiency)
• Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. (Required proficiency)
• Medical terminology comprehension. (Required proficiency)
• Ability to self-monitor progress and complete assigned tasks independently. (Required proficiency)
• Good judgment, initiative and problem solving skills. (Required proficiency)
• Ability to follow through and consistently demonstrate primary job responsibilities are current. (Required proficiency)
• Excellent computer skills with working knowledge / proficiency in a variety of software environments (ie Excel, Access, Word, database applications) and ability to learn document management systems (Required proficiency)
• Society of Clinical Research Associates (SoCRA) (Preferred)
• ACRP Certified Professional (ACRP-CP) (Preferred)

Demonstrates expertise in quality assurance and clinical research management, with a strong understanding of US regulatory requirements, including FDA and ICH/GCP guidelines. Proficient in process improvement, documentation, and training program development within clinical trial environments.