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 within relevant regulatory regulations.
Monitors and manages ongoing documentation, regulatory, and policy changes and up-dates 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.
USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying.
Minimum Education: Bachelor's degree Additional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 5 years Minimum Skills: Extensive clinical research experience, and experience monitoring clinical research studies. Experience with medical terminology, and with the drug development process. Demonstrated experience with Good Clinical Practices (GCP), ICH guidelines, and pertinent FDA regulations. Proven ability to interpret and apply all relevant federal, state, and local laws, regulations, and policies regarding clinical trials and monitoring. Ability to work effectively and independently at a senior level in a highly decentralized and varied setting. Demonstrated strong interpersonal skills to deal effectively and tactfully with staff at all levels. Proven ability to communicate effectively, both verbally and in writing. Demonstrated planning, problem-solving, and management skills. Preferred Education: Master's degree Preferred Experience: 10 years 6 years of experience monitoring clinical research studies. Preferred Skills: Demonstrated experience with Microsoft Office suite, specifically Excel and PowerPoint, and/or any other relevant presentation software/tools.