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 Alzheimerâs Disease (AD) through innovative clinical trials.
Incumbent will provide oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operation Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements(s).Â Duties will include but are not limited to:
Supports study design, generation of study protocol, CRF, informed consent, and other study material.
Supports medical monitoring during study conduct, answers site questions on inclusion/exclusion criteria or other protocol questions, evaluates and assesses SAEs and AEs, reviews laboratory and other safety parameters, reviews patient profiles, reviews coded terms for medical history, concomitant medications, adverse events during course of study.
Performs MedDRA coding
Attends and/or presents at investigator, internal and external project team meetings.
Assesses and evaluates protocol deviations and recommends on actions to be taken.
Contributes to discussions with investigators, opinion leaders, internal and external clients.
Interacts with site clinical monitors to provide medical support
Provides benefit/risk evaluations and drug safety expertise for drugs
Contributes to and reviews Safety Management Plans, Medical Monitoring Plans, Pharmacovigilance Plans, Risk Management Plans including design and conduct of safety studies.
Evaluates spontaneous reports and literature cases.
Communicates with reporting site investigators and site staff regarding medical and safety issues.
Location:Â San Diego, CA
Salary is dependent on education and experience.
Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum educationMinimum Experience: 3 yearsMinimum Field of Expertise: Directly related professional experience in area of program specialization.
Internal Number: REQ20085898
USC’s Viterbi School of Engineering has been one of the economic engines in Southern California and a vital hub in the California economy. The technical innovations and ideas generated by the Viterbi faculty and research community have resulted in countless innovations, many becoming the foundations for new companies, products and services. The thousands of students graduating each year bring new ideas and vitality to companies in California and beyond. With an annual research budget exceeding $205M each year, more than 46 research centers and institutes, more than 180 faculty members, 7,800 students and over 60,000 impassioned alumni world-wide, the Viterbi School is addressing some of the world’s great challenges.