Assistant Clinical Research Coordinator - 134182

UCSD Department of Psychiatry is one of the most innovative and productive academic departments in the country, offering challenging career opportunities in the diverse areas of advanced educational programs, cutting-edge research, and state-of-the-art clinical services. The department is committed to offering a dynamic learning environment and growing opportunities to its talented and dedicated employees.

The incumbent will work as an Assistant Clinical Research Coordinator to be responsible for coordinating and managing clinical trials within the Department of Psychiatry that performs clinical and neuroscientific research on mindfulness as a treatment of chronic pain, opioid use, and substance use disorders. The incumbent will work closely with the Principal and Sub-Investigators to provide all aspects of protocol management, including participant recruitment, screening for participant eligibility, data collection and analysis, ensuring protocol compliance, monitoring participant treatment and retention, and maintenance of accurate and complete clinical research files. The incumbent will liaise and correspond with 1) the Institutional Review Boards (IRBs) overseeing the trial including submitting human subjects applications, modifications, renewals, and ongoing safety reports; and 2) NIH and VA Cooperative Studies Program regulatory and monitoring entities. The incumbent will directly communicate with, schedule, and work alongside the study clinicians, including attending weekly meetings. The incumbent will provide direct assistance to the Principal Investigator and Fund Manager in reviewing and verifying university research account statements, purchase ordering, and invoicing.

• Theoretical knowledge of behavioral sciences such as psychology, neuropsychology, and cognitive neuroscience; or biomedical and related clinical sciences, as typically attained by a Bachelor's degree in one of these or a related field, or an equivalent combination of education and experience.

• Experience performing clinical research duties in a clinical research environment.

• Experience using electronic data capture (eDC) applications such as REDCAP. Knowledge of database, word processing and spreadsheet applications such as Access, Excel and MS Word.

• Experience with clinical trials participant or study subject recruitment and retention.

• Experience coordinating study startup activities, monitoring visits

• Experience providing in-service training to various research personnel on protocols, processes, and procedures.

• Experience maintaining files and keeping records.

• Excellent planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately.

• 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.

• Ability to work independently. Ability to maintain confidentiality.

• Experience completing clinical trials case report forms via hard copy and online.

• Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.

• Certification as a Clinical Research Associate or Coordinator.

• Experience working with research bulk accounts. Experience working with UC accounting and procurement systems.

• Experience working with UC systems.

• Experience with investigational drug authorization criteria.

• Experience obtaining neuropsychological and clinical assessments (i.e., electrocardiograms (ECGs), vital signs (blood pressure, heart rate, body temperature, body mass index) data and values and experience in interpreting them to determine participant eligibility and potential toxicities.

• Experience working with FDA policies regulating clinical trials including adverse event assessment and reporting.

• Experience in neuropsychological assessment and patient interviewing to determine participant impairment as defined by protocol management.

• Experience interpreting medical charts and 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.

• Employment is subject to a criminal background check and pre-employment physical.

• Occasional overtime, evenings, and weekends may be required.