Clinical Research Coordinator - 135293

The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellows and postdocs and 480 staff personnel.

Incumbent will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects. 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-III 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 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.

Oversee Clinical Trials Administration and Regulatory compliance, coordination and documentation of specified pharmaceutical and device clinical trials and protocols. Responsible for development of protocols and execution of procedures. Responsible for ensuring that all procedures comply with regulatory procedures and standard operating procedures. Design case report forms for PI initiated and Sponsor provided protocols.

Responsibilities include the development and maintenance of all study related documents and procedures for the FDA, CRO and Pharmaceutical Company; oversee execution of protocols to be conducted at the site; and coordinate, assign, and evaluate the activities of in-house coordinating staff to ensure FDA Compliance and Good Clinical Practice. This position will require developing, updating and refining of Standard Operating Procedures. Additionally, responsible for study recruitment, including the innovation of screening process to improve patient and clinical trial databases. Responsible for performing protocol defined procedures as required. Independently collect and analyze scientific data for publication, identify and develop new clinical trial protocols, train and monitor research staff, medical students, fellows, hospital nurses assigned to these protocols. Incumbent is required to use Velos, a mandatory clinical trials management system that is used to track all patients enrolled in a clinical trial, track all scheduled visits and individual events performed at each visit and is used for studies that have a conventional care coverage analysis.

• 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 biomedical 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 especially with cardiology protocols (data management, query resolution, protocol design, protocol writing 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.

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

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

• 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.

• 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 Masters Degree.

• Experience working with United States Food and Drug Administration (FDA) policies regulating clinical trials.

• Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.

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

• Occasional evenings and weekends may be required.