Assistant Clinical Research Coordinator - 134221

The UCSD Department of Obstetrics, Gynecology and Reproductive Sciences is composed of 65 faculty and clinical fellows. The department is composed of 6 divisions: Obstetrics and Gynecology, Maternal-Fetal Medicine, Gynecologic Oncology, Reproductive Endocrinology and Infertility, Hospitalist, and Urogynecologic and Reconstructive Surgery.

Reporting directly to the Research Supervisor of OB/GYN and Reproductive Sciences, the incumbent will be responsible for recruiting subjects and collecting samples and clinical data for studies.

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. 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 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 clinical trials participant or study subject recruitment.

• 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.

• 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.

• Ability to speak, read, write in Spanish is preferred.

• 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 coordinating study startup activities.

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

• Experience completing clinical trials case report forms via hard copy and online.

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

• Must have access to reliable transportation.

• Must be willing to travel off-site.

• Must have current Phlebotomy certification or be willing to undergo training for certification for Phlebotomy (a 6-week course including 2 weekends, paid by the department).

• Must be willing to work evenings and weekends.