Clinical Research Coordinator - 138296

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. Assure 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.

• 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. 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).

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

• Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.

• 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 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.

• 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 in conducting searches on the internet.

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

• Possess a Clinical Research Coordinator Certificate, or Masters Degree.

• Employment is subject to a criminal background check and pre-employment
• Occasional evenings and weekends may be required.