DESCRIPTION

Department of Pediatrics is one of the largest departments within the UCSD School of Medicine with comprehensive clinical programs, extensive basic science and clinical research, and diverse educational opportunities for students, residents and fellows. The internationally renowned faculty play a major role in medical and graduate student training, providing educational and programmatic offerings that span several disciplines, and provide diversity to meet the interests of a broad spectrum of students and scholars. More than one hundred trainees at the graduate student and postdoctoral level, as well as more than 300 professional, research and administrative staff who along with the department administrators interact closely with the faculty. The diverse mix of ages, backgrounds, and talents creates a robust work environment with challenging career opportunities and a commitment to continued growth potential. We constantly seek to recruit highly motivated, technologically-advanced and interested individuals to become a part of our dynamic cutting-edge research, clinical, and educational environment.

The UCSD - Rady Pediatric Emergency Department is the largest emergency department in all of San Diego County. We are committed to providing excellent emergency care to approximately 103,000 children every year. Join our physician-scientists in expanding efforts to treat acutely ill and injured children through a diverse research scope that includes Kawasaki Disease, MIS-C, mental health crisis, quality improvement, and health disparities research. Be a cornerstone in creating a unique pediatric emergency research infrastructure and experience rewarding contributions to the children of San Diego every single day.

Under the general direction of the Research Administration Team at the Division of Pediatric Emergency Medicine, the Lead Research Coordinator will independently perform and oversee the clinical research efforts for a variety of research projects and clinical trials in the pediatric emergency department.

Drawing on experience with Industry, National Institutes of Health (NIH), and society sponsored research, the incumbent will monitor study participant compliance, evaluation and quality assurance procedures, oversee the quality of clinical and research data and write annual reports; oversee the regulatory process for site, Institutional Review Board (IRB), research compliance and Food and Drug Administration (FDA) audits, and ensure compliance of Health Insurance Portability and Accountability Act (HIPAA) regulations of patient confidentiality throughout the studies, manage the acquisition, preparation, and distribution of patient financial compensation.

The incumbent will contribute original ideas for developing, improving, and implementing study protocols, offering insight at the regulatory, operational, clinical, and technical levels. Incumbent will oversee 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.

Incumbent will draft and assist in the drafting of manuscripts as an author or coauthor. Manuscript contributions will include study design, collage/figure design and creation, analysis of manuscript data, and completion and submission of manuscript. The candidate will be responsible for assigned aspects of grant proposal preparation and submission, including technical writing and editing, budget preparation, and aiding in compliance with federal, state and university regulatory requirements for funded research.

Key to this role is the preparation of study protocols, related regulatory documents, and progress reports for submission to the IRB; oversight and management of laboratory operations, such as ordering lab and study supplies, keeping up to date on safety protocols, clinical billing recharges, and IRB approval and maintenance. This includes acting as a liaison for numerous investigators and staff.

Incumbent will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, monitoring patients, and maintenance of accurate and complete clinical research files. Create informational and recruitment materials and act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies. The Clinical Research Coordinator will plan, develop and implement start-up procedures for multiple phase I-IV research studies in assigned disease team as well as lead, direct, and coordinator operational efforts. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Provide education and information to the public concerning the ongoing clinical trials. Assist PIs with proposals, progress reports and manuscripts. Independently create original documents and policies for assigned disease teams. Work closely with federal and state regulatory officials.

MINIMUM QUALIFICATIONS

• Strong theoretical knowledge and Bachelor’s degree in social science or basic science such as Biology, Microbiology or a related field and/or an equivalent combination of education and work experience.

• At least two (2) years of demonstrated experience working in a clinical research environment including knowledge of medical terminology.

• Working knowledge of medical and scientific terminology.

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

• 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.

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

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

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

• 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.

• Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.

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

• Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.

PREFERRED QUALIFICATIONS

• Certification as a Clinical Research Associate or Coordinator.
• Bilingual in English and another language.

SPECIAL CONDITIONS

• Job offer is contingent upon satisfactory clearance based on Background Check results.
• Occasional evenings and weekends may be required.
• 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.