DescriptionPosition Summary/Essential Duties: Coordinate activities within the Quality Assurance Program for the Clinical Research Unit. (20%)Establish and implement process improvement projects. (5%)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. (20%)Ensures that clinical trials are initiated, documented and reported in compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations. (20%)Create and maintain an education and training program for the Clinical Trial Unit. (10%)
Independently coordinate training and mentoring of new hires. Tailor and coordinate training plan for QA new hire based upon individual's past experience. Identify areas of training need; assign training activities with QA specialists and/or other functional team members; assess progress; and act as mentor for new hire. (25%)
Bachelor's degree required and 5 years quality assurance or clinical trial monitoring experience required. Advanced degree preferred.
Experience & Knowledge:
Requires five years of either quality assurance or clinical trial monitoring experience required, including sound knowledge of US regulatory requirements for clinical research including FDA, ICH/GCP
Required Credentials, License and/or Certifications: Research certification preferred (ie SoCRA, ACRP)
Special Skills & Equipment Knowledge:
Outstanding organizational skills, oral and written communication skills and strong attention to detail. Strong interpersonal skills and ability to work as an effective team leader. Sound knowledge of state and federal regulatory guidelines. Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. Medical terminology comprehension required. Ability to self-monitor progress and complete assigned tasks independently. Good judgment, initiative and problem solving skills. Ability to follow through and consistently demonstrate primary job responsibilities are current. Excellent computer skills with working knowledge / proficiency in a variety of software environments required (ie Excel, Access, Word, database applications) and ability to learn document management systems.
Location/Region: Cleveland, OH (44101)