Clinical Research Coordinator Assistant - Psych - 139326

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.

Under supervision, the incumbent will provide research protocols and treatments within multiple new study initiatives that include treatment resistant psychiatric disorders and studies with healthy and high-performing participants within the Department of Psychiatry. The primary duty will be delivery of research protocols using neuromodulation, neuroimaging, psychedelic therapies (e.g. ketamine/psilocybin), and behavioral recordings. Methodologies used include repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS), electroencaphlography (EEG), and functional magnetic resonance imaging (fMRI), among others. Duties may also include: IRB submission support; recruitment and retention of research subjects; coordinating subject appointments with facilities and staff; neurophysiology experimental assistance; and data collection. Responsibilities could include administering diagnostic interviews; acquiring confidential and sensitive information including medical/mental health history; and administer neurocognitive assessments and symptom rating scales. Duties also include maintenance of accurate and complete clinical research files; update study databases and ensure compliance with standardized protocol, and assistance with the preparation of manuscripts and presentations. The applicant will also perform other duties as needed including assist with annual IRB and NIH reporting.

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. Provide direct assistance to the Project Manager in reviewing and verifying university research account statements, professional fee statements, and invoicing.

• Theoretical knowledge of biology, social sciences, clinical sciences as typically attained by a Bachelor's degree, or an equivalent combination of education and experience such as experience administering neuromodulation treatment (TMS treatments).

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

• Research experience with patients with mental health illnesses.

• Knowledge of interventional psychiatric treatments such as Transcranial Magnetic Stimulation (TMS), ketamine, and psychedelic therapies.

• Technical abilities with methodologies such as functional MRI, EEG, and/or Transcranial Magnetic Stimulation (TMS).

• 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.

• Working knowledge of FDA policies regulating clinical trials.

• Exposure to medical assessment and patient interviewing to determine toxicities related to 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.

• Experience with clinical trials participant or study subject recruitment.

• Experience coordinating study startup activities.

• Exposure to in-service training on various protocols, processes, and procedures.

• Knowledge of x-rays, scans, and other diagnostic 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.

• Exposure to 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 with investigational drug authorization criteria.

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

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

• Must be flexible and willing to work at on-campus and off-campus locations - potentially moving between locations based on needs.