Assistant Clinical Research Coordinator - Medicine - 140312

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.

Reports directly to the leadership of the Cardiovascular Clinical Research Unit (CCRU) or delegated research supervisor. Assists with the coordination and implementation of clinical research studies, including participant screening, scheduling study visits, data collection and entry, specimen processing and shipment, maintenance of study records, and support of protocol-required activities while ensuring compliance with study procedures and regulatory requirements.

Provides operational support for clinical trials, including assisting with adverse event documentation, monitoring visit preparation, maintenance of accurate research files, and coordination of communications among study participants, investigators, and study staff. Assists the regulatory department with Human Subjects submissions, continuing reviews, safety reports, and maintenance of regulatory documentation.

Participates in assigned research team meetings, educational sessions, and disease-specific conferences as appropriate. Provides support to the Project Manager, Regulatory Manager, or Clinical Research Coordinator with study tracking, financial documentation, invoice preparation, and reconciliation of research-related expenses and payments.

Under supervision, the Assistant Clinical Research Coordinator will assist in the coordination of multiple federally funded and industry-sponsored clinical research studies involving human subjects conducted within the UC San Diego Cardiovascular Institute and affiliated locations. Assist with study initiation, implementation, and day-to-day management activities while ensuring compliance with protocol requirements, institutional policies, and applicable state and federal regulations.

Responsibilities include participant recruitment and screening; obtaining study-related measurements such as vital signs, ECGs, height, and weight; scheduling study visits; coordinating clinical, laboratory, and data collection activities; processing and shipping laboratory specimens; collecting and entering research data; maintaining accurate study records and subject files; and supporting the timely documentation and reporting of adverse events, toxicities, and protocol deviations.

Maintain study and participant information in University-approved clinical research systems, including the Clinical Trial Management System (CTMS/VELOS), and assist with the organization and maintenance of regulatory, source, and study documentation to ensure completeness, accuracy, and audit readiness.

• 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 including a Clinical Research unit.

• 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 test results to determine patient eligibility and potential adverse events in line with the Cardiovascular Clinical Research protocols.

• Experience working with FDA policies regulating clinical trials.

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

• Experience interpreting electronic and paper 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 for industry initiated and industry funded projects.

• Experience coordinating study startup activities for industry initiated and industry funded projects.

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

• Knowledge of x-rays, scans, and other cardiology diagnostic procedures including but not limited to Cardiac CT, Cardiac MRI, Angiography etc.

• 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 electronically or hard copy. Experience with creation of the study specific case report forms. Experience with creation of projects in the REDCap.

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

• Certification as a Clinical Research Associate or Coordinator.

• Bilingual in English and Spanish.

• 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.

• Must be able to work various hours and locations based on business needs.