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San Diego Supercomputer Center · 2 days ago

Clinical Research Coordinator - 138075

San Diego, CA

Full-time

Onsite

Mid Level

$37.61/hr - $60.48/hr

The San Diego Supercomputer Center is part of the UCSD School of Medicine, focusing on research and clinical missions. The Clinical Research Coordinator will oversee start-up procedures, manage recruitment and enrollment of subjects, and ensure compliance with regulatory guidelines for multiple clinical trials.

Big DataDatabaseInformation Technology

Comp. & Benefits

Responsibilities

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

Plan, develop and implement start-up procedures for multiple phase I-III research studies in assigned disease team as well as 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 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

Develop and maintain 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

Develop, update and refine Standard Operating Procedures

Responsible for study recruitment, including the innovation of screening process to improve patient and clinical trial databases

Perform 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

Qualification

Clinical Trials ResearchProtocol DesignRegulatory ComplianceData ManagementClinical Research Coordinator CertificateMedical TerminologyMicrosoft OfficeInterpersonal SkillsProblem SolvingOrganizational Skills

Required

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

Preferred

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

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