Assistant Clinical Study Coordinator (PM Shift)

Job Description

The Assistant Clinical Study Coordinator is primarily responsible for the coordination of activities associated with the setup and management of clinical studies performed in the laboratory under the direction of, or as delegated by a member of the Clinical Production team. Responsibilities will range from clinical study coordination to data entry projects and general office work.

• File, track, and maintain Investigator Site Files (ISF) and Site Study Binders (SSB) to meet ICH/GCP requirements and work in conjunction with Clinical Study Coordinators to create and execute on study-specific plans and protocols
• Assist with preparing records for trial monitoring activities and study binder maintenance
• Assist team with study supplies management
• Conduct study tracking activities (sample status, reconciliation activities, filing & archiving)
• Assist with meeting coordination: scheduling meetings, meeting agendas, meeting minutes, meeting materials (creating PowerPoint Presentations as directed by senior team members)
• Support quality review of study documentation
• Involvement in process improvement initiatives regarding clinical studies and the lab
• Report all concerns of test quality and/or safety to the Supervisor or Safety Officer
• Perform other miscellaneous duties as assigned and assist others as time allows

Qualifications

• Bachelor’s Degree in biology-related field or equivalent healthcare or laboratory-related/project coordination work experience
• Background in biology, genetics, and/or medical terminology; interest in medical and/or clinical research career

• Able to prioritize and drive to results with a high emphasis on quality
• Able to integrate and apply feedback in a professional manner
• Proven attention to detail and accuracy
• High degree of initiative and self-motivation
• Able to work effectively in a team environment and build strong working relationships
• Effective interpersonal skills and the ability to effectively communicate (verbal and written) across all levels of the company.
• Experience with MS Office suite and Internet for business use

Additional Information

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment. Ability to sit for extended periods of time.

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

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