112320 - Assistant Clinical Research Coordinator
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#112320 Assistant Clinical Research CoordinatorFiling Deadline: Wed 10/27/2021
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 before they will be allowed on campus or in a facility or office. For more information visit: https://ucnet.universityofcalifornia.edu/news/2021/10/flu-vaccination-requirement-for-uc-students,-faculty-and-staff-issued-for-2021-2022.html
UCSD Layoff from Career Appointment: Apply by 10/15/2021for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 10/27/2021. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Department of Orthopaedic Surgery is a vibrant and growing Orthopaedic Surgery Department of 48 full-time faculty and 50 voluntary faculty, 4 physicians on MSP contracts, 32 trainees, and 34 staff that supports and participates in the academic, clinical, and research mission of UC San Diego. The Department generates over $12M in clinical revenue, and $5M (NIH & other) in research grants and contracts, with total annual expenditures exceeding $30M. The Department is a comprehensive orthopaedic group located in San Diego that offers a full spectrum of musculoskeletal clinical care, specializing in foot and ankle, hand, joint reconstruction, physical medicine and rehabilitation, spine, sports, and trauma. Research expertise includes advancements in muscle metabolism and physiology, neuromuscular bioengineering, intervertebral disc, and musculoskeletal physiology and epidemiology.
Reporting directly to the P.I. the Assistant Clinical Research Coordinato 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.
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 working with FDA policies regulating clinical trials.
Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.
Experience with clinical trials participant or study subject recruitment.
Experience coordinating study startup activities.
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 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 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.
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).
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
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