Ophthalmology Senior CRA Lead — Remote

Bayside Solutions

California

Remote

USD 69,000 - 83,000

Full time

2 days ago
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Job summary

Bayside Solutions is seeking an Ophthalmology Sr. Clinical Research Associate (LCRA) for a remote role (PST). The LCRA leads a CRA/CTA team to ensure timely initiation, enrollment, conduct, and completion of studies, while providing project management support and monitoring resources.

Responsibilities include guiding CRAs, ensuring SOP/regulatory compliance, managing TMF/eTMF, reviewing reports, and coordinating with sites, vendors, and clients. Travel may be required.

Qualifications

  • RN, Bachelor’s or advanced degree in biological sciences or related field.
  • 4–5 years of experience and prior CRA experience preferred.
  • Recent ophthalmology experience.
  • Knowledge of FDA regulations and GCP, SOPs, and data quality requirements.
  • Willingness to travel and perform remote and on-site monitoring as needed.
  • Proficiency with Microsoft Word, Excel and PowerPoint.

Responsibilities

  • Provide study oversight as primary liaison among CRAs, staff, investigators, and vendors.
  • Ensure monitoring activities comply with SOPs, regulations, and KPIs.
  • Develop and manage clinical plans, timelines, and monitoring intervals.
  • Create visit report templates and site management documents.
  • Support training and documentation for the team.
  • Guide CRAs, CTAs, and CROs on monitoring, co-monitoring, and audits.
  • Oversee TMF/eTMF filing and quality control.
  • Track SAE, protocol deviations, enrollments, ICFs, and supplies.
  • Perform qualification, initiation, interim and close-out visits as needed.

Skills

Leadership
Communication
Organization
Prioritization
Presentation
Problem solving
Attention to detail

Education

RN / Bachelor’s / Biological sciences degree

Tools

Microsoft Word
Excel
PowerPoint

Job description

Bayside Solutions is seeking an Ophthalmology Sr. Clinical Research Associate (LCRA) for a remote role (PST). The LCRA leads a CRA/CTA team to ensure timely initiation, enrollment, conduct, and completion of studies, while providing project management support and monitoring resources.

Responsibilities include guiding CRAs, ensuring SOP/regulatory compliance, managing TMF/eTMF, reviewing reports, and coordinating with sites, vendors, and clients. Travel may be required.

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