Clinical Operations Specialist

We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with. 

Overview

Provides support to Study Management and other study team members.  Responsible for in-house site management.  Manages all 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 sponsor and site. 

Responsibilities

• Site feasibility process (e.g., questionnaire development, collection, and tracking)
• Contribute to creating Study Informed Consent template and route for Clinical Lead and Sponsor review for approval prior to central IRB submission 
• Complete Local ICF Site and Study Level Checklists and route for Clinical Lead review and approval prior to central IRB submission
• Develop other patient-facing materials (e.g., subject diary, questionnaires, etc.)
• Prepare and manage central IRB submissions - liaise with central Institutional Review Board (IRB) 
• Update site-specific information in CTMS
• Liaise with the Project Specialist (PS) to draft the site section of the eTMF Plan
• Contribute to development of Regulatory Binder Table of Contents and template study logs and forms 
• Track site activation activities
• Collection of regulatory documents from site
• Ancillary supply management at the site level, including ordering, reconciliation, re-supply requests, Regulatory Binder contents, and printed materials
• Follow up with sites on pending items needed for site activation
• Draft and send site activation letter to site upon approval from Clinical Lead 
• Administer site enrollment surveys
• Perform ongoing site file reconciliation
• Perform eTMF audits and reviews
• Send mass study communications to sites after review and approval from the Clinical Lead
• File and maintain all site level documents in the eTMF
• Contribute to creating the Monitoring Plan for Clinical Lead review and approval
• Provide final EDC subject data to sites with support from the CTA
• Provide Site Reconciliation Reports
• Run Study User Access Reviews
• Perform eTMF document QC
• Perform debarment checks on potential Study PIs and record findings in CTMS
• Open and close file reviews in eTMF

Requirements

Education:

BA/BS in a science/health care field, nursing degree, or equivalent combination of education and experience

Experience:

• At least 1 to 2 years of clinical research coordinating experience or experience working in a contract research organization (CRO) or pharmaceutical or biotechnology company is preferred
• Competent computer skills including MS Office Suite
• Experience working with eTMF and EDC systems is preferred 

Skills:

• 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 Project 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

Physical Requirements

Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lif