Bachelor's degree in Biological Science or related field
2 years of on-site clinical trial monitoring experience
Industry experience in pharmaceutical, biotechnology, or clinical research settings
Familiarity with ICH-GCP guidelines and FDA guidance documents
Strong technical documentation and data organization skills
Excellent interpersonal communication skills
Preferred: Master's degree in Neurosciences, Public Health, or Pharmacology
Preferred: CCRA or CCRC certification
Responsibilities
Collaborate with Project Director to define clinical trial scopes and objectives
Assess feasibility and prioritize clinical projects
Implement and manage clinical trial protocols across multiple sites
Develop written materials to guide study site execution
Create and monitor standard operating procedures and guidelines
Serve as the primary contact and expert for assigned projects
Organize and execute training for principal investigators and study staff
Benefits
Comprehensive health insurance
Retirement savings plan
Professional development opportunities
Flexible work arrangements
Supportive work environment focused on collaboration
Full Job Description
Collaborates with Project Director and other functional groups to develop clinical trial scopes of work and objectives. Assesses feasibility of clinical projects, identifies project priorities, enforces project timelines, and ensures that milestones are met. Operationalizes, implements and manages clinical trial protocols at multiple study sites. Develops written materials to guide study sites in clinical trial execution. Collaborates with other functional groups to create, revise, implement and monitor standard operating procedures (SOP) and internal procedural guidelines. Serves as point of contact and guidance expert for assigned projects and studies. Organizes and executes training for site principal investigators and study staff.
Minimum Education: Bachelor's degree In Biological Science Or in related field(s)
Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years in on-site clinical trial monitoring.
Minimum Skills: Industry experience in a pharmaceutical, biotechnology, clinical research organization and/or nursing setting Demonstrated experience using medical devices and terminology. Experience applying policies and procedures, with some familiarity with ICH-GCP guidelines and working knowledge of FDA guidance documents. Skilled at technical documentation and writing, and at assembling, organizing and conceptualizing numerical data in spreadsheets, databases, reports and presentations. Lead/guidance skills, with the ability to manage and prioritize different tasks and projects. Deft interpersonal skills for communicating with all levels of staff and various individuals and groups coordinating and executing study activities. Preferred Education: Bachelor's degree And Master's degree In Neurosciences Or Public Health Or Pharmacology Or in related field(s)
Preferred Certifications: Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC). Preferred Experience: 4 years Preferred Skills: Experience in data management. Excellent written and verbal communication skills to express complex ideas to study staff at research and clinical institutions. Ability to handle several priorities within multiple, complex clinical trials. Strong understanding of current GCP guidelines applicable to the clinical research conduct. Proficient in OmniPlan or other timeline applications. Familiarity with academic medical centers.
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$156428.htmld
About University of Southern California
The University of Southern California (USC) is a private research university located in Los Angeles, California. It was founded in 1880 and is the oldest private research university in California. USC offers undergraduate, graduate, and professional degree programs in a wide range of fields, including business, law, engineering, medicine, and the arts. The university is known for its strong athletic programs, particularly in football and basketball. USC has a diverse student body, with students from all 50 states and more than 100 countries. The university has a total enrollment of approximately 47,000 students, including 28,000 undergraduate students.
