Clinical Research Coordinator - 134569

The Department of Surgery is one of the largest departments in the School of Medicine and is comprised of 102 full time faculty members, 220 voluntary faculty members, 20 physicians employed on MSP agreements, 25 doctors employed by the VA or other facilities, 77 accredited and 13 non-accredited trainees and 100 career staff. Activities are organized in 13 sub-specialty divisions. Annual expenditures across the Department total over $66.5M with a global research portfolio of over $19M. The missions of research, education and patient care are intertwined, and are integral to the goals of the department.

As a leader in research and patient care, the UC San Diego Department of Surgery is committed to providing the latest in expert and compassionate treatment, performing leading-edge research, and training the next generation of top surgeons and scientists. UC San Diego Health is currently ranked among America's best hospitals by U.S. News & World Report.

Under supervision, the Clinical Research Coordinator will be assigned to multiple clinical research studies involving human subjects within the research unit/department. This position initiate, implementation and management of research projects in accordance with GCP, FDA, HIPAA & all required regulatory guidelines, with an emphasis on pediatric clinical research studies. Responsibilities may include initiating & managing multiple research projects, including but not limited to clinical trials, PI-initiated studies, and other research projects. Responsibilities may include but are not limited to submission of protocols & renewals to IRB & scientific review boards; management & submission of electronic data forms to Sponsors, CROs & regulatory agencies; screening for eligibility; monitoring and timely reporting of adverse events; toxicities and protocol deviations; scheduling subjects' visits; coordinating clinical, laboratory and data management activities; processing and submitting laboratory specimens. Interfaces with patients/subjects & the Principal Investigators (PI) as well as working with assigned division's inpatient & outpatient clinical staff & other departments within the Institution. Coordinates preparation for monitor visits, regulatory & data audits. May support and/or supervise interns or staff depending on nature of study. If needed under study-specific research protocol, may collect basic vitals and clinical data based on study needs under the supervision and training of the study PI.

• Theoretical knowledge in a social science or basic science such as Biology, Microbiology or a related field and/or an equivalent combination of education and work experience.

• Demonstrated experience in clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design, and evaluation.

• Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.

• Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).

• General understanding of computer software and hardware: Word, Excel, data entry (ex. Any EDC platform such as REDCap, Medidata, Rave.

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

• Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities.

• Ability to discern items that can be handled independently and those which require attention of supervisor, including ability to quickly determine subject matter of material and necessary action to be taken in a timely manner.

• Working knowledge of medical and scientific terminology.

• Proven ability to problem solve and resolve conflict.

• Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.

• Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills.

• Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience inconducting searches on the internet.

• Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

• Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or equivalent Clinical research certification through SOCRA for ACRP.

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

• Occasional evenings and weekends may be required.