ICU Asst. Clinical Research Coordinator - 133919

The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel.

Under supervision from Principal Investigator and Clinical Research Supervisor II in the Pulmonary, Critical Care & Sleep Medicine Division, the Research Coordinator supports the ICU clinical research efforts for a variety of research projects and clinical trials focusing primarily on pulmonary disorders including COPD, cystic fibrosis and IPF. Responsible for independently coordinating and managing research studies, to include protocol management, screening for patient eligibility, consenting subjects, data collection and entry, patient follow-up, query resolution, and database management. The Research Coordinator will assist in the conduct of Clinical Trials by ensuring protocol compliance, filing adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Will independently process Institutional Review Board (IRB) submissions and amendments.

Reporting directly to Clinical Research Supervisor II, 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 in biology, immunology, 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.

• Demonstrated knowledge of FDA policies regulating clinical trials.

• Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.

• Demonstrated 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 with interpretation and understanding of research protocols in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.

• Experience maintaining files and keeping records.

• Demonstrated knowledge of IRB and Human Subjects Research requirements, to include the informed consent and Patient's Bill of Rights.

• 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 skills, including excellent written and verbal communication skills; ability to with a diverse group of people to include physicians, patients and their families.

• 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.

• Demonstrated experience using database, word processing and spreadsheet applications.

• Demonstrated experience working in a Pulmonary & Critical Care Office or clinical research environment including knowledge of pulmonary medical terminology.

• Demonstrated experience working with patients with Pulmonary Hypertension or similar respiratory diseases either in a clinical or research setting. Knowledge of diagnostic studies used and medications used to treat pulmonary hypertension.

• Must have access to reliable transportation.

• Experience with investigational drug authorization criteria.

• Certification as a clinical research associate or coordinator.

• Experience working with research bulk accounts.

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

• Must be willing to travel to occasional meetings and work weekends and evenings as needed.

• Must be willing to work with human blood and biohazardous materials.