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Description

The Senior Clinical Research Coordinator oversees the operational management of clinical research activities, including study design, setup, execution, and closeout. Responsible for the implementation of research activities across multiple studies, this role involves task prioritization to meet deadlines while ensuring adherence to study protocols and regulatory standards, such as institutional policies, FDA CFR, and ICH GCP. Collaboration with Principal Investigators, ancillary departments, central research teams, sponsors, and institutions is key to ensuring compliant study conduct, financial oversight, and adequate personnel support. Duties may vary based on department needs, study type, and service scope.

Salary: $39.61 - $63.73 hourly

Qualifications

Required:

+ Minimum of 4+ years of experience in a clinical research setting

+ Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team.

+ Ability to effectively communicate to and interact with patients in a compassionate and kind manner.

+ Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations.

+ Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.

+ Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment.

+ Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met.

+ Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately.

+ A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently.

+ Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc.

+ Strong verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to- understand manner.

+ Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines.

+ Ability to handle confidential information with judgement and discretion.

+ High degree of concentration and focus in a work environment that contains distracting stimuli, competing deadlines, and work delegated by more than one individual.

+ Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc..

+ Strong knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc.

+ Strong knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.

+ Ability to think creatively to develop solutions affecting the full team.

+ Experience with FDA processes and procedures.

+ Sufficient experience and knowledge of clinical trials budgeting processes to manage the preparation of clinical trials budgets

+ Bachelor's degree or equivalent experience/training

Preferred:

+ Master's degree

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