San Diego Supercomputer Center · 5 hours ago
Clinical Research Coordinator - 138293
San Diego, CA
Full-time
Onsite
Mid Level
$37.61/hr - $60.48/hr
3+ years expThe San Diego Supercomputer Center is part of UC San Diego and is seeking a motivated and experienced Clinical Research Coordinator to assist in clinical trials in neuromuscular medicine. The role involves coordinating and overseeing research studies, ensuring compliance with regulatory guidelines, and managing various operational efforts related to clinical trials.
Big DataDatabaseInformation Technology
Responsibilities
Coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, documentation, data entry and maintenance of subjects
Create informational and recruitment materials and liaise with other UCSD departments and agencies to implement studies
Plan, develop, and implement start-up procedures for multiple phase I-IV research studies in assigned disease teams
Lead, direct, and coordinate operational efforts
Assure compliance with state and federal regulatory guidelines
Oversee the quality of the medical and clinical research data
Build and maintain regulatory documents consistently from start up to close out
Provide direction and guidance to investigators
Provide education and information to the general public concerning the ongoing clinical trials
Work closely with Sponsor, clinical trials organizations, federal and state regulatory officials
Oversee the administration of clinical trials and ensure full compliance with regulatory requirements and institutional policies
Coordinate and document pharmaceutical-sponsored and investigator-initiated clinical trials and protocols
Involve with protocol development, oversight of study execution, and ensuring that all study procedures adhere to Standard Operating Procedures
Design and develop case report forms (CFRs) for both PI-initiated and Sponsor-funded protocols
Oversee execution of protocols to be conducted at the research site; and monitor the in-house research staff to ensure FDA regulations and Good Clinical Practice (GCP) standards
Create, refine, and regularly update Standard Operating Procedures
Oversee study recruitment strategies, including the development and implementation of innovative screening processes to enhance patient enrollment and improve clinical trial processes
Perform protocol defined procedures as required
Independently collect and analyze scientific data for publication, identifying new clinical trial protocols, training and monitoring research personnel; including physical therapists, fellows, nurses or any other staff assigned to the incumbent protocols
Perform other duties assigned
Qualification
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 clinical trials research for a minimum of 3 years. Strong knowledge of Good Clinical Practice (GCP), FDA regulations for clinical trials research, randomization and blinding procedures, experimental protocols, data gathering, and data entry
Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures
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 implementation. Able to manage multiple (>10) vendors assigned to a single clinical trial
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 platforms
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 typing ability, working knowledge of word processing, spreadsheet software (Microsoft Office) and applications
Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions
Proficiency in written and spoken English
Able to efficiently manage and respond to emails in a timely fashion
Preferred
Possess a Clinical Research Coordinator Certificate, or Masters Degree
Proficiency with Velos, UCSD's mandatory clinical trials management system, used for tracking participant enrollment, scheduling, visit completion and conventional care coverage analysis
Company
San Diego Supercomputer Center
SDSC enables science and engineering discoveries through advances in computational science and data-intensive, high-performance computing.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
National Science Foundation
2024-12-05Grant
Leadership Team
Ilkay Altintas
Division Director, Cyberinfrastructure and Convergence Research and Education
Recent News
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