Incumbent will support 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). Duties will include but are not limited to:

• Supports 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.
• Communicates with reporting site investigators and site staff regarding medical and safety issues.
• Interacts with medical monitors and site clinical monitors to provide support to medical safety team
• Contributes to development of Safety Management Plans, Medical Monitoring Plans, Clinical Monitoring Plans, Pharmacovigilance Plans, and Risk Management Plans
• Assists in performing MedDRA and WHODrug coding
• Attends and/or presents at investigator, internal and external project team meetings.
• Assists in overseeing the Medical Safety Specialist team within the Medical Safety unit
• Interacts with industry and academic partners
• Assists in scientific manuscript writing and editing

Preferred Education & Experience:

• Medical degree or equivalent in medical-related field or life science
• 3+ years of experience or graduate degree (master's or doctoral)
• Understanding of Alzheimer's disease and/or the drug development process
• Experience in interacting with cross functional study team members

Knowledge, Skills, and Abilities:

• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations
• Knowledge of ICH Guidelines regarding development phases, clinical research, and medical writing standard
• 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 and attention 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 and escalate complex issues appropriately
• Excellent interpersonal, active listening, and influencing skills; establishes and maintain 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

Location: San Diego, CA

The annual base salary range for this position is $99,102.14 - $141,885.98. 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.

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.

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