"Clinical Monitor Line Manager"

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California, is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer’s Disease (AD) through innovative clinical trials.

The Medical & Safety team within ATRI is looking for an experienced Clinical Monitoring Line Manager with strong supervisory skills and a background within clinical trials. Duties will include but are not limited to:

• Oversees Clinical Monitors for sponsor and investigator initiated clinical research
• Responsible for managing study site assignments, daily operations, monitor metrics reviews, and data query placements, and closures
• Ensures site qualifications, initiations, monitoring, and study closeout visits are conducted in accordance with relevant regulatory regulations.
• Monitors and manages ongoing documentation, regulatory, and policy changes and updates for clinical monitoring procedures
• Serves as primary communications liaison for clinical monitoring and study teams
• Develops and administers ongoing clinical trial education, creating instructional and coaching plans for certified, appropriate staff qualifications and training
• Recruits, screens, interviews, hires, and supervises clinical monitors
• Responsible for all clinical monitor training and ongoing clinical trial education for monitors
• Responsible for conducting performance evaluations, setting goals and providing counsel when appropriate
• Travel to study sites, collecting and analyzing delivery, productivity, and performance metrics of Clinical Monitors

Job requirements

• Knowledge and experience within clinical trials
• In-depth knowledge of Good Clinical Practices (GCP), ICH, IRB, FDA, & HIPAA guidelines
• Experience leading successful teams
• Ability to train, recognize where training is needed, and coach team members
• Strong written and verbal communication skills

Location: San Diego, CA

The annual base salary range for this position is $143,310.82 - $170,878.68. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.