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 (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.