University of Southern California

Research university in Los Angeles, CA

Medical Monitor

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeSan Diego, CA, USA$97.4k - $136.3k /yrIn-person

About the Job

Requirements

A bachelor's degree is required, with combined experience and education accepted as a substitute for the minimum education requirement.
At least 3 years of related experience with specialized research and/or programs is required, with combined experience and education accepted as a substitute for the minimum work experience.
Related experience with specialized research and/or programs, such as counseling or teaching, is required.
Ability to analyze and evaluate data and present findings is required.
Excellent interpersonal and written and oral communication skills, including the ability to problem-solve and lead conflict resolution, are required.
Ability to interpret and apply policies, analyses, and trends is required.
A thorough knowledge of clinical research concepts, practices, and FDA regulations is required.
Knowledge of ICH guidelines regarding development phases, clinical research, and medical writing standards is required.
Ability to interpret and apply guidelines to document writing is required.
Ability to work independently with minimal supervision, multitask, work effectively under pressure, adapt to change, and apply project management skills and attention to detail is required.
Ability to communicate with teams to set realistic timeline expectations, deliver within internal and regulatory timelines, monitor and communicate progress against milestones, and appropriately escalate complex issues is required.
Ability to establish and maintain professional and productive working relationships with team members is required.
Ability to use a balanced approach to problems, applying flexibility and persistence as appropriate, is required.
Fluent English reading, writing, and speaking skills are required.

Responsibilities

Support medical monitoring during study conduct by assisting with site questions about inclusion and exclusion criteria or other protocol questions, and assisting with evaluation of adverse events and serious adverse events, laboratory and other safety parameters, medical history, and concomitant medications.
Assess and evaluate protocol deviations and recommend actions.
Communicate with reporting site investigators and site staff regarding medical and safety issues.
Interact with medical monitors and site clinical monitors to support the medical safety team.
Contribute to developing Safety Management Plans, Medical Monitoring Plans, Clinical Monitoring Plans, Pharmacovigilance Plans, and Risk Management Plans.
Assist with MedDRA and WHODrug coding.
Attend and/or present at investigator, internal, and external project team meetings.
Assist in overseeing the Medical Safety Specialist team within the Medical Safety unit.
Interact with industry and academic partners.
Assist with scientific manuscript writing and editing.

Desired Qualifications

A master's degree is preferred.
A medical degree or equivalent in a medical-related field or life science is preferred.
At least 5 years of related experience with specialized research and/or programs is preferred.
Understanding of Alzheimer's disease and/or the drug development process is preferred.
Experience interacting with cross-functional study team members is preferred.
Related special education, licensing, or certifications based on program content and services are preferred.
Proven ability to lead and guide others is preferred.

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 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 $97,417.05 - $136,262.82. 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.

USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. 

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 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 observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to theBackground Screening Policy Appendix Dfor specific employment screen implications for the position for which you are applying.

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 [email protected]. Inquiries will be treated as confidential to the extent permitted by law.

If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser:

https://wd5.myworkday.com/usc/d/inst/1$9925/9925$156469.htmld

About the Company

University of Southern California

Research university in Los Angeles, CA

The University of Southern California is a private research university with academic programs across the arts, sciences, business, engineering, law, health, and other professional fields.

Company size: Not listed
Company stage: Not listed
Total funding: Not listed
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