Clinical Research Coordinator

Overview

UC San Diego Health is home to San Diego’s most comprehensive care program for patients with Amyotrophic Lateral Sclerosis (ALS) and is a worldwide leader in ALS clinical research. The ALS Clinical Research Program (ACT) is the epicenter of such research at UCSD, including sponsor-funded and investigator-initiated clinical trials.

The incumbent, under the guidance of the study investigators and the clinical research supervisor, will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, and subject maintenance. Create informational and recruitment materials and liaise with other UCSD departments and agencies to implement studies. The Clinical Research Coordinator will plan, develop, and implement start-up procedures for multiple phase I-III research studies within assigned disease teams, and will lead, direct, and coordinate operational efforts.

Ensure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide education and information to the general 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.

• Coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, and subject maintenance for ALS-related clinical trials.
• Create informational and recruitment materials and liaise with UCSD departments and agencies to implement studies.
• Plan, develop, and implement start-up procedures for multiple phase I-III research studies within assigned disease teams; lead, direct, and coordinate operational efforts.
• Assure compliance with state and federal regulatory guidelines.
• Oversee the quality of medical and clinical research data.
• Provide education and information to the general public concerning ongoing clinical trials.
• Assist principal investigators with proposals, progress reports, and manuscripts.
• Independently create original documents and policies for assigned disease teams.
• Work closely with federal and state regulatory officials.

• Strong theoretical knowledge and/or Bachelor’s Degree 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 with knowledge of experimental protocols, data gathering, protocol design and evaluation.
• Experience in research protocol start-up procedures, including study feasibility, study activation and IRB processes, and qualification procedures; experience in budget negotiations and invoicing per clinical trial agreement.
• Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).
• Experience performing clinical research duties in an academic research institution and/or a research hospital.
• Experience with screening patients for eligibility, initiating treatment plans, collecting specimens, and orienting participating physicians.
• Experience completing clinical trials case report forms via hard copy and online.
• Ability to find creative and innovative solutions to the center’s needs; resourcefulness and understanding of overall work responsibilities to establish useful resources and University contacts.
• Ability to discern tasks that can be handled independently and those needing supervisor attention; ability to determine subject matter and necessary actions in a timely manner.
• Working knowledge of medical and scientific terminology.
• Proven problem-solving and conflict resolution skills.
• Excellent ability to organize/prioritize workload to meet deadlines in a dynamic environment with changing priorities; meticulous attention to detail.
• Excellent interpersonal, written, and verbal communication skills with grammatically correct English and accurate typing; ability to interact with a variety of personalities and promote positive working relationships.
• Strong computer proficiency (word processing,…