Nationwide
Northern & Central California, California
Bethlehem, Pennsylvania
Sacramento, California
Alexandria, Virginia
Central, South Carolina
New York, NY, 10176, USA
Columbia, SC
Posted: 16-Dec-22
Location: La Jolla, California
Salary: Open
Internal Number: 120642
UCSD Layoff from Career Appointment: Apply by 12/14/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 12/27/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.
Placement within the salary range is determined by internal equity, relevant qualifications, and collective bargaining agreements (when applicable).
DESCRIPTION
The Alzheimer's Disease Cooperative Study (ADCS) was formed in 1991 as a cooperative agreement between the National Institute on Aging (NIA) and the University of California, San Diego. The ADCS is a multi-center clinical trials consortium that provides an operational framework for large scale Alzheimer's disease research projects. The ADCS consists of 7 cores, 22 committees, 35 research sites that are members of the consortium/Steering Committee, and an additional 40 or more research sites located across the U.S. and Canada that participate in one or more trials coordinated by the ADCS. Annual funding for the ADCS ranges from $15-$25M. The ADCS provides expertise in developing Alzheimer's disease related protocols and is the coordinating center for multiple clinical trials of varying sizes and complexity under subcontracts funded by NIH and clinical trial agreements with industry partners.
Reporting directly to the Director of Clinical Operations, this position is responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Assist the regulatory department with Human subjects submissions, renewals, and safety reports. Directly communicate with assigned physicians and disease groups, including attending weekly meetings and tumor boards. Provide direct assistance to the Project Manager in reviewing and verifying university research account statements, professional fee statements, and invoicing.
MINIMUM QUALIFICATIONS
Theoretical knowledge of biology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's degree, or an equivalent combination of education and experience.
Experience performing clinical research duties in a clinical research environment.
Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word.
Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.
Experience working with FDA policies regulating clinical trials.
Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.
Experience interpreting medical charts, experience in abstracting data from medical records.
Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.
Experience with clinical trials participant or study subject recruitment. Experience coordinating study startup activities.
Experience providing in-service training to various research personnel on protocols, processes, and procedures.
Knowledge of x-rays, scans, and other diagnostic procedures.
Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a diverse population. Excellent phone etiquette skills.
PREFERRED QUALIFICATIONS
- Certification as a Clinical Research Associate or Coordinator.
- Experience working with research bulk accounts.
- Experience with investigational drug authorization criteria.
SPECIAL CONDITIONS
- Employment is subject to a criminal background check and pre-employment physical.
- Occasional evenings and weekends may be required.
Pay Transparency Act Full Salary Range: $62,619 - $100,746 Annually
The University of California, San Diego is required to provide a reasonable estimate of the compensation range for this role. This range takes into account the wide range of factors that are considered in making compensation decision