University of Southern California
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USC’s Keck School of Medicine, Department of Medicine, is seeking a Project Manager.
USC’s Keck School of Medicine, Department of Medicine, is seeking a Project Manager to join its team. The Project Manager is part of the Medicine Research Unit (MRU) and is responsible for providing oversight and support for ACCELERATE-PACE NIH Grant within the Division of GI/Liver.
The Project Manager works closely with the Principal Investigator and Data Coordinating Center on day-to-day operations of this multi-center research grant. The candidate’s duties include:
- Contribute to the development of the ACCELERATE-PACE clinical protocol, informed consents and clinical study reports; prepare/review clinical trial documents including project agreements, CRFs and study plans/manuals, as appropriate.
- Coordinate operational aspects of the study implementation and daily operations, from protocol design to the final clinical study report.
- Define timelines for study start-up and apply knowledge to evaluate progress.
- Maintain communications with a multi-disciplinary trial team made up of both internal and external team members, including but not limited to the study clinicians, site staff, vendors, data managers, and administrative staff.
- Identify and anticipate potential study management or operations issues and collaborate with investigators and research staff to resolve these barriers to the study’s success.
- Develop or oversee the development of training materials, including site initiation visit materials, clinical examination-specific trainings, and other trial-specific training opportunities, in consultation with investigators.
- Conduct at least quarterly in-person or virtual site visits to monitor operations and provide quality assurance oversight to preserve the rights and safety of research participants.
- Propose and negotiate alternatives to improve project implementation as needed.
- Provide overall management to ensure that safety concerns and/or Adverse Events/SAEs and protocol deviations are properly reported and tracked
- Implement a robust quality management system to ensure compliance IRB and NIH requirements.
- Serve as the primary resource for all ACCELERATE-PACE regulatory matters
- Prepare submissions to institutional review boards for study protocols, using IRB submission platforms, and respond to queries, in consultation with the Principal Investigator.
- Contribute to the research team in preparing abstracts and presentations related to research projects.
- Orient and train new staff on ACCELERATE-PACE study materials, including USC and all participating study sites
- Provide guidance and mentorship to junior investigators and coordinators on international research implementation.
- Supervise all ACCELERATE-PACE study staff based at USC
- Perform other related functions, as assigned.
Rate Information:
This position will be Exempt and Hybrid-Flex.
The salary range for this position is $92,097-113,100.
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.
Other Information:
Preferred Education: Masters Degree
Preferred Experience: 7 years in clinical research
Preferred Field of Expertise: Clinical Research
Percentage of Time: 100%
Fixed Term? No
Minimum Education: Master’s degree, Combined experience/education as substitute for minimum education
Minimum Experience: 5 years, Combined education/experience as substitute for minimum experience
Minimum Field of Expertise: Directly related education and project administration experience in specialized field represented by project
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