Bachelor's Degree or 10 years of clinical research or quality assurance experience
5+ years in quality assurance or clinical research
3+ years of clinical research management experience with knowledge of US regulatory requirements
Outstanding organizational and communication skills
Strong interpersonal and leadership abilities
Detail-oriented with time management skills
Proficient in medical terminology and computer applications
Responsibilities
Coordinate quality assurance activities within the Clinical Research Unit
Perform quality assurance reviews of study documents across multiple studies
Assist in optimizing departmental management control systems and implement process improvements
Ensure compliance with internal SOPs and regulatory guidelines in clinical trials
Create and maintain an education and training program for the Clinical Trial Unit
Benefits
Opportunities for professional development and continuing education
Access to a supportive work environment conducive to teamwork
Exposure to diverse therapeutic areas and clinical study phases
Comprehensive onboarding and training experiences
Flexible work environment with occasional travel opportunities
Full Job Description
What You Will Do
Coordinate activities within the Quality Assurance Program for the Clinical Research Unit. (20%)
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. (30%)
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. (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%)
Additional Responsibilities
Performs other duties as assigned.
Complies with all policies and standards.
For specific duties and responsibilities, refer to documentation provided by the department during orientation.
Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
Qualifications: Education
Bachelor's Degree or 10 years of either clinical research experience or quality assurance experience or combination of both (Required)
Master's Degree (Preferred) and
Work Experience
5+ years of either quality assurance or quality control experience or clinical research experience or combination of both; (Required) and
3+ years of clinical research management experience including sound knowledge of US regulatory requirements for clinical research including FDA, ICH/GCP (Required)
Knowledge, Skills, & Abilities
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)
Licenses and Certifications
Society of Clinical Research Associates (SoCRA) (Preferred) and
