Assistant Clinical Research Coordinator - 135591

Biomedical Informatics is an interdisciplinary field at the intersection of biology, medicine, and quantitative sciences. Biomedical Informatics researchers develop new methods to integrate and analyze vast amounts of data generated in the laboratory, clinical and translational research, clinical encounters, and population studies.

The goals of the Department of Biomedical Informatics (DBMI) are to (1) promote excellence in biomedical informatics research, (2) collaborate with biomedical researchers in developing new quantitative methods that enable the formulation and testing of original hypotheses, (3) train the next generation of biomedical informatics specialists, and (4) interface with engineering, mathematics, information and computer science communities, serving as a hub for quantitative scientists focused on biomedical research.

This department leads multiple federally and non-profit funded biomedical research projects, which are focused on the integration, analysis, and sharing of biomedical and health care data for the scientific community, as well as patient-centered research. In addition, the department runs a complex computational infrastructure that allows access and analysis of these data in a privacy-preserving manner.

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, 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. Will recruit, consent, and perform venipuncture/phlebotomy on patients.

• Must be a Certified Phlebotomy Technician I (CPT I) by the State of California. Phlebotomy training, certification, and experience, with demonstrated ability to perform venipuncture/phlebotomy on patients with difficult venous accessibility.

• 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.

• Knowledge of database, word processing and spreadsheet applications such as REDCap, Excel and MS Word.

• 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.

• 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.

• 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 with the ability and willingness to make a large volume of recruitment calls per day.

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

• Ability to work independently. Ability to maintain confidentiality.

• Experience interpreting medical charts, experience in abstracting data from medical records.

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

• Experience coordinating study startup activities.

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

• Experience maintaining files and keeping records.

• Experience completing research data collection via hard copy and online.

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

• Fluency in both English and Spanish.

• Certification as a Clinical Research Associate or Coordinator.

• 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.

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

• Experience working with research bulk accounts.

• Experience with investigational drug authorization criteria.

• Phlebotomist certification required. Spanish speaking preferred.

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

• Occasional evenings and weekends may be required.

• Required to hold a valid California driver's license, have a driving record that is in accordance with local policies/procedures, and/or enroll in the California Employer Pull Notice Program. Must be willing and able to travel.

• Will be responsible for driving own vehicle and/or commuting to various locations in community and to UCSD for training.

• Must maintain auto insurance at levels required by UCSD.