Glaukos

Clinical Research Associate

Glaukos • $80K — $95K *
San Clemente, CA 92672In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • Minimum of 4 years' work experience as a CRA
  • 8 years direct clinical research experience
  • Bachelor's degree in biological science, nursing, or related discipline preferred
  • Preferred experience in medical device and pharmaceutical industry
  • Ophthalmology experience strongly preferred
  • Knowledge of Good Clinical Practices (ICH E6 R2)
  • Understanding of FDA regulations for clinical research
  • Proficient in Microsoft Office
  • Willingness to travel approximately 75-80%
  • Self-directed individual

Responsibilities

  • Conduct site qualification, initiation, and monitoring visits
  • Assist in selecting potential investigators
  • Train site staff on study procedures
  • Monitor compliance with study protocols and regulations
  • Evaluate data collection accuracy and resolve queries
  • Review and verify site regulatory documents
  • Lead regular contact with site staff to manage study progress
  • Monitor subject safety and address protocol deviations
  • Maintain documentation and provide FDA inspection support
  • Mentor/training for new CRAs

Benefits

  • Generous leadership-driven culture
  • Innovative and family-oriented work environment
  • Commitment to social responsibility
  • Focus on employee development and continuous improvement
  • Opportunities to work with cutting-edge technologies in ophthalmology
Full Job Description
Job Description

How will you make an impact?

Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The Clinical Research Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level.

What will you do?

CLINICAL SITE MONITORING
  • Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits
  • Assist with selection of potential investigators
  • Conduct initial and ongoing site training throughout the course of the study Verify informed consent process is properly followed
  • Evaluate investigator compliance with the study protocol and applicable regulations
  • Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries
  • Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed
  • Verify and reconcile site's essential documents against the trial master file as required
  • Oversee and conduct monitoring activities, including remote monitoring when applicable
  • Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study

CLINICAL SITE MANAGEMENT
  • Assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study
  • Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance
  • Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity
  • Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability
  • Monitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sites.
  • Create and maintain appropriate documentation (e.g., visit reports/letters)
  • Works independently with seldom supervision
  • Mentor/train new CRAs
  • Conduct peer to peer review visits
  • Provide FDA inspection support
  • Maintain strong productive relationships with study investigators, site staff, and study management personnel, including assessment and resolution of existing relationship issues
  • Participate in the development of source document templates, CRFs, CRF completion guidelines, monitoring plans, etc.
  • Executes department projects


How will you get here?
  • Clinical coordinating experience in ophthalmology required
  • Degree in biological science, nursing, or other related discipline preferred, or direct work experience
  • Experience medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels
  • Knowledge and understanding of Good Clinical Practices (ICH E6 R2)
  • Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinical research studies
  • Must have proficient computer skills and experience with Microsoft Office
  • Must be willing and able to travel approximately 75-80%, including overnight, domestic and international
  • Must have Self-directed behavior
  • Ideally will be located in Western US


#GKOSUS

About Glaukos

Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company's second-generation MIGS device, the iStent inject, was approved by the FDA in June 2018. Glaukos is also developing a pipeline of innovative technologies in corneal health, including the recently acquired Microline surgical platform, as well as novel drug delivery technologies.
Learn more about Glaukos
Size
727 employees
Market Cap
$1.9 billion
Industry
Healthcare
Net Income
-$120.3 million
Founded
1998
5 Year Trend
+20.8%
Revenue
$224.9 million
NASDAQ
GKOS
* Ladders Estimates

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