Project Specialist - Reading Center

Lexitas

7h • $65,000 - $75,000 • Remote

About The Position

Provides support to Study Management and other study team members. Responsible for in-house site management. Contributes to protocol-level and investigator-related clinical trial documents, study supplies and vendor information. Keeps study-related essential documentation current and filed. Facilitates collection and review of essential documents, budgets/contracts and IRB documentation on behalf of sponsors and sites. Serves to support standardized, anonymized, and objective grading of study images by trained graders. Produces accurate and unbiased image grading.

Requirements

• BA/BS in the science/health care field, nursing degree, or equivalent combination of education and experience
• At least 2 years of clinical research coordinating experience or experience working in a contract research organization (CRO), pharmaceutical, or biotechnology company is preferred
• Competent computer skills including MS Office Suite
• Experience working with eTMF and EDC systems is preferred
• Customer service oriented
• Demonstrates good communication skills (written and verbal)
• Attention to detail
• Manner of interactions demonstrates an understanding of the value of developing positive relationships
• Ability to plan and organize information and activities as directed by a Study Manager or team member
• Able to resolve routine problems and elevate issues appropriately
• Able to work remotely in a fast-paced environment that requires effective multi-tasking and ability to easily adapt to changing priorities
• Works well as part of a dynamic project team, actively supporting other team members and identifying opportunities to contribute
• Proficient technical software and computer processes
• Effective and efficient with time management

Responsibilities

• Supports grading, quality checks, and quality control of Cornea and/or Retinal reads from the imaging types (according to assigned study, but not limited to): Spectral Domain Optical Coherence Tomography (SD-OCT), Color Fundus Photography (CFP, UWF or 7-field), Optical Coherence Tomography Angiography (OCTA), Slit Lamp Imaging, Fundus Autofluorescence (FAF), Fluorescein Angiography (FA), Microperimetry (MP), Specular Microscopy (SM), Anterior Segment Optical Coherence Tomography (AS-OCT)
• Complete Training and maintain up-to-date training record: GCPs, Reading Center SOPs, Clinical management system training with Reading Center Project Manager or designee, Ophthalmic software training with Reading Center Project Manager or designee, Study Specific Protocols, Study Specific Image Reading Protocol
• Analyze ophthalmic images and identify/characterize features and pathologies according to reading center protocols
• Participate in adjudications with other reader(s)
• Record data in eCRFs
• Participate and attend Reading Center Meetings, as needed
• Contribute to quality improvements in grading and imaging protocols
• Perform site training and certification to site coordinators, photographers/technicians, PIs
• Issues/clears queries with sites and reviews responses
• Track all critical aspects of the study and communicate information to the study team, escalating issues as appropriate
• Responsible for collection and tracking of essential documents to/from sites
• Assist with the preparation of study materials such as newsletters, study logs, note to files, etc
• Generate draft meeting agendas, minutes and action items for study-related meetings, as needed
• Coordinate study team activities on behalf of study management
• Work on assignments requiring judgment and initiative. Understand implications of work and make recommendations for solutions
• Perform other tasks as directed by line management or project leadership

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level