Clinical Research Associate

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

Oversees and reviews site activities for clinical trials via on-site monitoring visits and/or in-house assessments according to the trial-specific monitoring plan. Oversees clinical site activities. Monitors trial records to verify the protection and well-being of study subjects and that reported trial data is adequate, complete and verifiable from source document data. Reviews site compliance with protocol, Good Clinical Practice (GCP), FDA regulatory requirements, and Standard Operating Procedures (SOPs). Frequent travel to study sites is expected.

Responsibilities

• Performs pre-study, initiation, interim monitoring and close out visits according to applicable SOPs, GCP and FDA Guidelines
• Monitors clinical studies at a site level, including the review of case report forms (CRFs) to ensure adherence to the current protocol and consistency and scientific validity of the data as verified against source document data
• Manages all aspects of a clinical study at assigned clinical trial sites to ensure subject safety and well-being, adherence to appropriate safety regulations and data integrity
• Provides technical, scientific, and operational guidance to study site personnel on the protocol
• Assists with the tracking and reporting of enrollment and works with site to identify enrollment issues, barriers, and strategies
• Implements project specific processes and tools
• Responsible for maintaining or gathering site/project specific information as directed by sponsor and project management
• Coordinates the collection and approval of essential and regulatory documents and maintenance of site study documentation
• Assists other team members with site-specific issues, acting as liaison between study staff and project staff
• Must be able and willing to travel as the project requires.
• Performs other tasks as directed by line management or project leadership

Requirements

Education:

• This position requires a B.S./B.A. in a health related or scientific field and a minimum of 2 years of experience in clinical research, or equivalent combination of education and experience

Experience:

• Experience in field monitoring as a Clinical Research Associate for a minimum of 6 months
• Knowledgeable about relevant GCP and FDA regulations as they relate to clinical trial compliance
• Strong preference for CRAs who have COA or COT certifications (or refraction experience)
• Experience in ophthalmology preferred
• Some experience in field monitoring preferred
• Ability to travel 60% to 70% of time

Skills:

• Highly customer service oriented
• Quality of interactions demonstrates an emphasis on developing and retaining strong relationships internally and externally
• Competent communication (both written and verbal), personable, able to develop a positive rapport with clinical sites
• Demonstrates analytical and problem-solving skills and appropriate judgement regarding issue identification and escalation
• Strong attention to detail
• Competent computer and organizational skills
• Works well independently and as part of a dynamic project team

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 a