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.Â Â Incumbent will assist the medical monitoring team in providing 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 Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements(s).Â Duties will include but are not limited to:Â
SupportsÂ medical monitoring during study conduct, assists in answering site questions on inclusion/exclusion criteria or other protocol questions, assists in evaluating AEs and SAEs, laboratory and other safety parameters, medical history, and concomitant medications.
Assesses and evaluates protocol deviations and recommends on actions to be taken.Â
Communicates with reportingÂ site investigatorsÂ and site staff regarding medical and safety issues.Â Â
Interacts with medical monitors and site clinical monitors to provide supportÂ to medical safety team
Contributes to development of Safety Management Plans,Â Medical Monitoring Plans, Clinical Monitoring Plans, Pharmacovigilance Plans, and Risk Management Plans
Assists in performing MedDRA and WHODrug codingÂ
Attends and/or presents at investigator, internal and external project team meetings.Â
Assists in scientific manuscript writing and editing
Knowledge, Skills and Abilities:
Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate
Read, write and speak fluent English; excellent verbal and written communications skills
Minimum Education: Bachelor's degree in medical-related field or life sciences, combined experience/education as substitute for minimum education
Minimum Experience: 3 years
Minimum Field of Expertise: Directly related professional experience in area of program specialization.
Post-graduate degree preferred
Bachelorâs degree 3+ years of experience or graduate degree (masterâs or doctoral) preferred
An understanding of Alzheimerâs disease and/or the drug development process
Experience in interacting with cross functional study team members
Location:Â San Diego, CAÂ
Salary is dependent on education and experience.Â Â Â
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.
USC is the leading private research university in Los Angeles—a global center for arts, technology and international business. With more than 47,500 students, we are located primarily in Los Angeles but also in various US and global satellite locations. As the largest private employer in Los Angeles, responsible for $8 billion annually in economic activity in the region, we offer the opportunity to work in a dynamic and diverse environment, in careers that span a broad spectrum of talents and skills across a variety of academic and professional schools and administrative units. As a USC employee and member of the Trojan Family—the faculty, staff, students, and alumni who make USC a great place to work—you will enjoy excellent benefits, including a variety of well-being programs designed to help individuals achieve work-life balance.