Assistant Clinical Research Coordinator - 133763

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 incumbent is responsible for the day-to-day coordination and execution of clinical trials including protocol management, subject screening and recruitment, informed consent, data collection and analysis, adverse event reporting, human subject monitoring, laboratory and specimen processing, and maintaining participant safety while adhering to Good Clinical Practice (GCP). Assist the regulatory department with IRB 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 study milestones, 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 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 completing clinical trials case report forms via hard copy and online.

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

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

• 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. 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 device/drug authorization criteria.

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

• Occasional evenings and weekends may be required.