Clinical Research Coordinator - 134795

Current UC San Diego Health Medicine employees who apply by 3/19/2025 will have priority consideration for this position. Recruiters will refer qualified internal candidates after the first 7 days of the job posting. All qualified external applicants and additional internal applicants who apply after the priority date may have further consideration pending the results of the initial review.

Under general direction, the Clinical Research Coordinator will be responsible for coordinating and managing clinical trials, which includes providing all aspects of protocol management - screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies. Assist with IBD Project Manager with the planning, development, and implementation of start-up procedures for multiple phase I-IV and other pharmaceutical and investigator-initiated research studies. Lead, direct, and help coordinate operational efforts in compliance with state and federal regulatory guidelines. Oversee the quality of medical and clinical research data. Provide direction and guidance to investigators and assist PIs with proposals, progress reports and manuscripts. Must be able to independently create original documents and policies for assigned disease teams and work closely with federal and state regulatory officials when/if indicated. Will be responsible for Human subjects submissions, renewals, and safety reports. Directly communicate with assigned physicians and disease groups, including attending weekly meetings. Provide direct assistance to the Project Manager in reviewing and verifying university research account statements, professional fee statements, and invoicing. Other duties assigned as needed.

• 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 CRO, academic research institution, and/or a research hospital.

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

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

• 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.

• Demonstrated knowledge of Gastroenterology medical terminology.

• Demonstrated knowledge of Irritable Bowel Disease research and implications.

• Knowledge of cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.

• Possess a Clinical Research Coordinator Certificate, or Master's Degree.

• Occasional evenings and weekends may be required.

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