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

Functions in a leadership capacity over the clinical function and monitoring team for a project.  Has mastered the clinical monitoring process, associated competencies and understands the role of clinical research in drug development. Is an expert on relevant Good Clinical Practice (GCP), ICH, FDA regulatory requirements, and Standard Operating Procedures (SOPs).  The Clinical Lead is responsible for quality and on time delivery of all tasks under the clinical function for each project assignment.

Responsibilities

• Train and mentor Clinical Research Associates (CRAs), and Clinical Operations Specialists, serving as subject matter expert.
• Serves as the first point of contact for CRA questions, managing the FAQ and triaging questions as appropriate.
• Lead CRA meetin
  gs and communications, ensuring effective site oversight and management
• Escalate and address critical or non-compliant site issues.
• Conduct Quality Control (QC) or Monitoring Visits at sites as needed.
• Conduct trending analysis on site issues and monitoring deviations, collaborating with the Project Manager to implement corrective actions.
• Identify suitable clinical trial sites and oversee Feasibility assessments.
• Oversee site activation, ensuring timely database build and User Acceptance Testing (UAT).
• Support Investigational Product (IP) release and resupply per protocols.
• Create and develop clinical study documents, including Monitoring Plans, Study Logs, Source Documents, Manual of Procedures, and Monitoring Tools.
• Create and annotate Monitoring Visit Trip Report Templates.
• Review Informed Consent Forms (ICFs) and site-level checklist templates for accuracy and compliance.
• Assist in the collection and assessment of essential clinical documents.
• Collaborate with Project Managers, Functional Management, and Senior Leadership on study deliverables, process improvements, and strategic initiatives.
• Support bid defense meetings, contributing to content development and presentation.
• Provide clinical management insights for internal and external study kick-off meetings.
• Liaise with the Medical Monitor as needed.
• Attend study meetings and provide weekly status reports to the Project Manager.
• Contribute to department-wide performance tracking, reporting on study status and key metrics.

Requirements

Education:

B.S./B.A. or advanced degree in a health-related or scientific field preferred. 

Experience:

• 5+ years of experience in the clinical research or pharmaceutical industry, or equivalent combination of education and experience. 
• Clinical Research Associate (CRA) experience preferred.
• Experience in ophthalmology preferred.

Skills:

• Must have mastered all core competencies of the Clinical Research Associate.  
• Exceptional organizational and management skills with the keen ability to prioritize multiple tasks with attention to detail.  
• Outstanding communication, both written and verbal skills, personable, able to develop a positive rapport with clinical sites and to lead and train, as needed other Clinical Research Associates. 
• Uses discretion and good judgement to address potential problems, elevating concerns to the next level of management when necessary. Understands clinical monitoring process and understands the role of clinical research associates in pharmaceutical drug development.  Knowledgeable about relevant GCP and FDA regulations as they relate to clinical trial compliance.  
• Some project travel is required.
• Must be highly customer service oriented and have creative initiative with a positive attitude. 
• Understands and shares the organizational values of developing and maintaining good relationships internally and externally.  Quality of interactions reflects emphasis on relationships. 
• Strong communication (both written and verbal), personable, able to develop a positive rapport with clinical sites.  
• Applies good judgment to address potential problems, elevating concerns to the next level of management when necessary. 
• Strong attention to detail. 
• Strong computer and organizational skills.  
• Proficiency in some software system(s) as appropriate for needs of department required. 

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.