• Work Location:

  San Jose (Primary), Santa Clara, Redwood City

• Required Education:

• Associate's degree in Science, Public Health, Health Care Administration, or a directly related

Required Experience:

Minimum one (1) of experience in clinical research or a directly related field.

JOB SUMMARY

The Clinical Research Coordinator I, Clinical Trials is a novice level position which, under the clinical direction of the Principal Investigator (PI), assists in the operational and administrative research support of the PI and Clinical Trials Operations Director or designee, and other research staff conducting multiple FDA-regulated clinical trials. This role collects data for clinical trials research, with guidance. May support clinical trials activities and research lab operations. Supports the timely, accurate, and complete documentation of all research activities (e.g., consent forms, reports0. Assists with the development and/or implementation of routine quality control and/or assurance measures and documents feedback to research staff and management, as instructed. Supports the education of research staff and/or participants on standard protocols, documentation procedures, clinical best practices, or timeliness of submissions, under guidance. Learns about the budgeting process. Learns to document clinical trials applications in compliance and consistency with all applicable federal, state, and local regulations and policies and procedures.

Additional Requirements:

• Satisfies requirements for career advancement/maintenance as defined by the Clinical Trial Career Ladder Program.
• Must be proficient in electronic health systems and databases used in research environment and word-processing or willingness to learn within 3 months of hire.
• Demonstrate organizational and communication skills.
• Demonstrate written, verbal, and interpersonal communication skills.
• Demonstrate proficiency in medical terminology.
• Demonstrate attention to detail and accuracy.
• Ability to manage multiple tasks.
• Demonstrate good prioritization and organizational skills.
• Ability to be flexible and dependable.
• Ability to work effectively on cross-functional teams.
• Present professional manner and appearance.
• Demonstrated skill in administrative tasks (i.e., filing, photocopying, faxing, etc.).
• Knowledge of GCP, federal, state, and local regulations including HIPAA and policies and procedures.
• Must be able to work in a Labor Partnership environment.

Preferred Qualifications:

• Clinical trials experience preferred.
• Only those lawfully authorized to work in the designated country associated with the position will be considered.
• Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.

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