Lexitas Pharma Services · 10 hours ago
Clinical Research Associate II
United States
Full-time
Remote
Mid Level
$100K/yr - $125K/yr
3+ years expLexitas Pharma Services is a purpose-driven organization focused on ophthalmic product development. They are seeking a Clinical Research Associate II to oversee site activities for clinical trials, ensuring compliance with protocols and regulations while monitoring subject safety and data integrity.
BiotechnologyClinical TrialsHealth Care
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
Proactively assists the team as needed and may be asked to mentor junior CRAs
Contributes to the project team by assisting in preparation of project documents/tools and sharing ideas/suggestions with team member
Qualification
Required
B.S./B.A. in a health related or scientific field
Minimum of 3 years of experience in clinical research, or equivalent combination of education and experience
Experience in field monitoring as a Clinical Research Associate for a minimum of 3 years with at least 1 year of ophthalmology monitoring experience
Knowledgeable about relevant GCP and FDA regulations as they relate to clinical trial compliance
Experience in ophthalmology required
Ability to travel 60% to 70% of time
Applicants must be based on the East Coast
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
Excellent attention to detail and the ability to keep detailed, accurate records
Competent computer, organizational and time management skills
Works well independently and as part of a dynamic project team
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
Preferred
Strong preference for CRAs who have COA or COT certifications (or refraction experience)
Company
Lexitas Pharma Services
Lexitas Pharma is a full-service CRO partnering with pharmaceutical and biotechnology companies specializing in ophthalmics.
51-200 employees
H1B Sponsorship
Lexitas Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2021 (3)
Funding
Current Stage
Growth StageTotal Funding
unknown2022-07-07Acquired
Leadership Team
Gaurav Bhatnagar
Sr Vice President- Strategy & Chief of staff to CEO
Tony Proctor
Chief Financial Officer
Recent News
The Business Journals
2023-12-23
2023-12-23
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