Clinical Monitoring Line Manager

University of Southern California•San Diego, CA

20h•Onsite

About The Position

The USC Keck School of Medicine – Alzheimer’s 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 seeking an experienced Clinical Monitoring Line Manager with strong supervisory skills and a background within clinical trials.

Requirements

Experience in clinical trials and team leadership
In-depth knowledge of ICH Good Clinical Practice (GCP), FDA CFR, and HIPAA guidelines
Excellent training, mentoring, and communication skills
Ability to analyze monitoring metrics and implement improvements
Ability to work as part of a management team and contribute to process development and improvements
Ability to travel up to 25%
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.

Nice To Haves

Master's degree
10 years
6 years of experience monitoring clinical research studies.
Demonstrated experience with Microsoft Office suite, specifically Excel and PowerPoint, and/or any other relevant presentation software/tools.

Responsibilities

Supervise, mentor, and train Clinical Monitors for sponsor and investigator initiated clinical research
Oversee study site assignments, monitoring deliverables, and team performance
Ensure compliance with institutional guidelines, ICH GCP, FDA CFR, HIPAA, Health Canada Division 5 and other country equivalents
Collaborate with team of managers and Lead Clinical Monitors on process improvement and staff development initiatives
Support study team with study conduct, regulatory inspections, audits, and coordinating center responsibilities
In conjunction with Lead Clinical Monitor, oversee assigned clinical studies ensuring that monitoring deliverables are met, collaborate with pharmaceutical and vendor partners, join/host study specific meetings, and contribute to other study specific initiatives
Recruit, screen, interview, hire, and supervise clinical monitor team members
Responsible for clinical monitor training and ongoing clinical trial education for clinical monitor team
Responsible for conducting performance evaluations, setting goals and providing counsel when appropriate
Travel to study clinical sites for onsite monitoring and monitor evaluation visits
Collect and analyze delivery, productivity, and performance metrics of Clinical Monitors