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
- 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
Salary is dependent on education and experience.
Minimum Education: Bachelor's degreeMinimum Experience: 5 yearsMinimum Field of Expertise: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 diverse 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..