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Description

The Assistant Clinical Research Coordinator contributes to the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. The position has responsibility for the coordination of research activities for one or more studies. The incumbent recognizes and performs necessary tasks to coordinate projects and prioritizes work to meet necessary deadlines. The incumbent participates in planning and organizing necessary tasks to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). The Study Coordinator collaborates with the Principal Investigator (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to support the administration of all aspects of studies, including, but not limited to, compliant conduct, financial management, and adequate personnel support. The responsibilities outlined in the job description provide a general overview of duties and tasks performed by Clinical Research Coordinators. Performance of duties and tasks will vary based on the department operations, the type of study and scope of service.

Qualifications

All Required

Minimum of 1+ 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. All Required

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.

Working knowledge of clinical research concepts, policies and procedures, and human safety

protection regulations and laws.

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-tounderstand 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. All Required

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

Preferred

Bachelor's degree

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