Clinical Monitoring Line Manager

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.  Duties will include but are not limited to:

• 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

Job 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%

Location:  San Diego, CA

The salary range for this position is $131,588.25 - $169,704.98. 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.

                                                  

USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. 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. 

We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at (213) 821-8100, or by email at uschr@usc.edu. Inquiries will be treated as confidential to the extent permitted by law.

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