Assistant Clinical Research Coordinator - Remote - 117086
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#117086 Assistant Clinical Research Coordinator - RemoteExtended Review Date: Fri 8/5/2022
For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus and influenza before they will be allowed on campus or in a facility or office. For more information visit: Flu Vaccine Mandate / COVID Vaccine Policy
This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 06/24/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 07/05/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.
Candidates hired into this position may have the ability to work remotely.
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 Assistant Clinical Research Coordinator will support clinical research efforts for a research program treating older adults with hoarding disorder by assisting with start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects within the Department of Psychiatry. Create informational and recruitment materials and act as a liaison with other UCSD departments, collaborators, and agencies for the purpose of implementation of studies. The Assistant Clinical Research Coordinator will assist with start-up procedures for multiple phase I-III research studies in assigned team as well as support operational efforts. The Assistant Clinical Research Coordinator will assist with multiple new study initiatives for treatment of hoarding disorder. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the clinical research data. Provide direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Assist PIs with proposals, progress reports and manuscripts. Independently create original documents and policies for assigned disease teams. Work closely with federal and state regulatory officials.
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.
Theoretical knowledge of Psychiatry, Psychology and/or other mental health services in social science, with emphasis on Severe Mental Illness (SMI) and Obsessive Compulsive Disorders (OCD) 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 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.
Experience providing in-service training to various research personnel on 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.
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.
Experience working with mentally ill individuals, including those demonstrating hoarding symptoms. Ability to demonstrate good clinical judgment.
Strong demonstrated experience in independently providing quality review of data quality reports generated by the Biostatistics team and Electronic Data Capture (EDC) edits prepared by the Informatics team.
Demonstrated experience in assisting with the Institutional Review Board (IRB) submissions for identified clinical trial sites.
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 and weekends may be required.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.
UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!
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UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html
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Job Reference #: 117086