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. Incumbent supports the medical safety team for sponsor and investigator initiated clinical research studies by applying their knowledge of ICH Good Clinical Practice guidelines,... more details
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.
Incumbent supports the medical safety team for sponsor and investigator initiated clinical research studies by applying their knowledge of ICH Good Clinical Practice guidelines, health authority regulations, and clinical research requirements to oversee clinical site processes, escalations, audits, CAPAs, and other clinical research needs. Incumbent ensures that study and site records are accurate, complete, timely, and compliant with relevant regulations and guidelines. Incumbent serves as communications liaison for clinical sites, clinical monitoring, medical monitoring, and study teams resolving and escalating any issues.
Overview:
This role will be pivotal in ensuring the smooth and compliant operation of clinical trials by effectively managing clinical site escalations, audits, CAPAs, and providing support across various audit processes as they relate to the medical safety team. The ideal candidate will have a strong background in clinical research, knowledge of ICH GCP, FDA CFR, FDA Bioresearch Monitoring Compliance programs, Health Canada regulations, EMA regulations, excellent communication and organizational skills, and the ability to navigate complex situations with professionalism and efficiency.
Key Responsibilities:
- Act as the primary point of contact for clinical site escalations from the medical and clinical monitoring teams, addressing issues promptly and effectively to ensure minimal impact on trial timelines and objectives, and following escalations through to resolution.
- Collaborate with clinical site staff, sponsors, and internal stakeholders to resolve escalated issues in a timely manner while adhering to protocol requirements and regulatory standards.
- Work directly with clinical sites to implement corrective and preventive actions (CAPA) as necessary to mitigate risks and prevent recurrence of issues at clinical sites.
- Coordinate with relevant stakeholders to gather necessary documentation, evidence, and information to ensure comprehensive preparation and response to various audits, including but not limited to FDA audits, sponsor audits, and internal audits ensuring compliance with regulatory requirements and company standards, including on-site visits and interactions with auditors, as needed.
- Ensure compliance with regulatory guidelines, Good Clinical Practice (GCP) standards, and internal quality management systems throughout all processes and interactions.
- Assist in the development and implementation of SOPs and best practices related to site management and compliance activities.
- Develops and administers clinical trial education and training.
- Support the oversight of clinical sites to ensure adherence to study protocols, regulatory requirements, and quality standards.
- Track and analyze site protocol deviations, providing guidance and support to sites as needed to address and resolve deviations effectively.
- Work closely with CRAs and investigators to identify trends, implement corrective actions, and improve overall site performance and compliance.
- Collaborate with internal teams on site performance metrics, process development, and overall site support.
- Conduct on-site visits to clinical sites to assess compliance, address escalations, support audit activities, provide on-site assistance and training, and foster strong relationships with site staff and investigators.
- Conduct other activities as needed to support the clinical research programs and medical safety team.
Qualifications:
- Bachelor's degree in clinical research, life sciences, pharmacy, nursing, or related field. Advanced degree preferred. Relevant experience may bypass degree requirement.
- Minimum of 5 years of experience preferred in clinical research or related field, with a focus on site management, site monitoring, audit response, and/or quality assurance.
- Strong understanding of US and Canada regulatory requirements, GCP guidelines, and clinical trial processes.
- Excellent communication skills, with the ability to effectively interact with diverse stakeholders both internally and externally.
- Proven problem-solving skills and the ability to navigate complex situations with diplomacy and professionalism.
- Detail-oriented with strong organizational skills and the ability to manage multiple tasks simultaneously. Ability to track and assess large datasets.
- Willingness to travel domestically and internationally as required (up to 20% travel).
The annual base salary range for this position is $101,821.40- $137,041.30. 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.
Minimum Education:
Bachelor's degree
Additional Education Requirements
Combined experience/education as substitute for minimum education
Minimum Experience:
3 years of related experience with specialized research and/or programs.
Addtional Experience Requirements
Combined experience/education as substitute for minimum work experience
Minimum Skills:
Related experience with specialized research and/or programs (e.g., counseling, teaching).
Ability to analyze and evaluate data, and present findings.
Excellent interpersonal and written and oral communication skills, able to problem solve and lead conflict resolutions.
Ability to interpret and apply policies/analyses/trends.
Preferred Education:
Master's degree
Preferred Experience:
5 years of related experience with specialized research and/or programs.
Preferred Skills:
Related special education, licensing, or certifications based upon program content and services.
Proven ability to lead and guide others.
USC is an equal opportunity, affirmative action 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 will consider for employment all qualified applicants with criminal histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring ordinance. 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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