Clinical Research Associate Job at USC, San Diego, CA

  • USC
  • San Diego, CA

Job Description

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 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 Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).  Duties will include but are not limited to:

  • Conduct onsite and remote monitoring for assigned clinical sites and co-monitor visits. Review Investigator Site Files, study data, perform IP reconciliation, review Informed Consent Forms, and other monitoring visit activities.
  • Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Work with sites to document deviations from standard procedures.
  • Review study data, issue and resolves queries. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance.
  • Act as main point of contact for assigned clinical sites.
  • Thorough understanding of study protocol and manuals.
  • Work closely with Lead Clinical Monitor/Lead CRA to escalate site compliance issues.
  • Participate in monitoring activities to achieve study milestones.
  • Utilize internal and study specific software and tools.
  • Assist in training new monitors on study specific or onsite procedures as needed.
  • Participate in sponsor, internal, and regulatory audits as needed.
  • Participate in eTMF filing efforts as needed.
  • Experience in AD research is preferred.
  • Up to 50% travel may be required.

Location:  San Diego, CA

The hourly rate range for this position is $42.91 - $51.94. 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, Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Field of Expertise: Monitoring of clinical trials and medical terminology. Knowledge of the drug development process.Thorough knowledge of ICH guidelines and Good Clinical Practices (GCP). Understanding of FDA regulations pertaining to Good Clinical Practices.Thorough knowledge of local and/or country’s regulation pertaining to clinical trials and monitoring.

Job Tags

Hourly pay, Work experience placement, Local area, Remote job,

Similar Jobs

Fred Hutchinson Cancer Research Center

Courier I Job at Fred Hutchinson Cancer Research Center

 ...organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion. The Courier I is responsible for the pick-up, transportation and delivery of lab specimens, medical records, medications, and patient related... 


Game Master/Game Host Job at Escapology

 ...Escapology is the worlds fastest growing escape game franchise, with over 79 operating around the world. Based at our store in El Paso, we are seeking Game Masters and Game Hosts to join our team as we open the store to guests. The successful applicants will become... 


Security Guard Job at AFIMAC Canada

 ...AFIMAC is seeking licensed Security Guards for upcoming projects throughout the province of Ontario. ***Please note this is a temporary contract position, so it may not be suitable to someone currently working full time*** You will earn approximately $1,872.00 per week... 

Domino's Franchise

Delivery Driver - 10595 Airline Hwy Job at Domino's Franchise

Not just your driver knocking, it's your future unlocking! Join our team where every door can lead to so much more. Drivers can earn$15-$20plus a SAFE driving bonus! RPM Pizza is the largest Dominos franchise in the United States for over 40 years, is family...

Our Lady of Hope Clinic

Bilingual Phlebotomist Job at Our Lady of Hope Clinic

Bilingual Phlebotomist (English/Spanish) at Our Lady of Hope ClinicLocation:6255 University Avenue, Ste 204Middleton, WI 53562About Us:Our Lady of Hope Clinic is a non-profit organization committed to providing quality healthcare services within the Catholic Healthcare...