Job Description

Clinical Study Assistant

Hybrid - On-site in Irvine, CA every Monday, Wednesday and every other Friday

JOB GOAL:

Provides administrative and organizational support for assigned clinical trials and sites in accordance with Good Clinical Practice (GCP), guidelines, standards, federal regulations and SOPs. Close collaboration with other members within Clinical R&D. Effectively manages multiple clinical study start activities to assure accurate and timely initiation for assigned clinical trials.

RESPONSIBILITIES:

• Serving as internal support for all members of assigned teams.
• Supporting investigative sites toward completion and appropriate submission of all required clinical trial documents prior to site initiation.
• Supporting establishment and maintenance of the electronic Trial Master Files(eTMF) for assigned clinical trials.
• Coordinating Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
• Supporting overall progress of clinical trials by regularly attending clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites, as requested by the Study Manager, Lead CRAs, CRA sand other clinical trial team members.
• Assist the study team with study startup procedures, including preparing site binders.
• Assisting assigned clinical trial teams to ensure that each clinical trial maintains audit/inspection readiness at each site and internally throughout the duration of assigned clinical trials.
• Ensuring all equipment/supplies provided to investigative sites is appropriately tracked and reported to Study Manager and/or Lead CRA during study startup
• Assist with contracts and purchase orders. Ensuring investigational product and, as applicable clinical supplies accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated.
• Preparing, submitting and filing of quality monitoring visit reports and associated follow-up letters in a timely manner.
• Providing regular updates to the Investigator of assigned investigative sites, Study Manager and/or Lead CRA with respect to study conduct and compliance
• Monitoring overall progress of clinical trials by regularly attending project and/or clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites, Study Managers, Lead CRAs, CRAs and other clinical trial team members.
• Maintaining audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
• Supporting study payment activities or accruals, as assigned.
• Ensuring all equipment/supplies provided to investigative sites is appropriately reported to Study Manager and/or Lead CRA.

QUALIFICATIONS:

Minimum education required for competent performance:

• BA/BS or equivalent years of experience required.

Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:

• 0-2 years of clinical research experience
• Knowledge of ophthalmology highly desirable but not required.
• Ability to problem-solve.
• Good communication via written, verbal and listening skills.
• Ability to report to corporate offices for routine, daily work.
• Ability to successfully manage multiple competing priorities and adapt quickly to changing priorities.
• Ability to problem-solve.
• Proficiency with MSWord, Excel and PowerPoint.

Equipment usage and abilities needed:

• Medical Device industry experience is preferred.
• Knowledge of ophthalmology is preferred.
• Strong knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials, is required.
• Ability to successfully manage multiple competing priorities and adapt quickly to changing priorities is preferred.
• Ability to problem-solve is required.
• Effective communication via written, verbal and listening skills, with ability to effectively deliver training or informational presentations at internal or external meetings is preferred.
• Proficiency with MS Word, Excel and PowerPoint is required.
• Proven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate is required.

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