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 co... more details
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
- Lead/manage 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) regarding site management, monitoring visit findings, and action plans
- Ensure audit and inspection readiness of assigned sites
- Advise on pre-audit activities for GCP requirements
- Be familiar with assigned study timelines and communicate potential issues to study management
How will you get there?
- Works independently under direct supervision from Manager or Mentor
- 0 to 2 years work experience as a regional CRA; 3 years direct clinical research experience or ophthalmology clinic experience
- Bachelor's degree in biological science, health science, nursing, health related area, or equivalent clinical experience required
- Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels of a CRA
- 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 70%, including overnight, domestic and international
- Must have Self-directed behavior
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.
Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we’re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Check out our profile on The Muse to get an inside look at our company culture. Glaukos Corporation has been Certified as a Great Place to Work the last two years!
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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
- Lead/manage 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) regarding site management, monitoring visit findings, and action plans
- Ensure audit and inspection readiness of assigned sites
- Advise on pre-audit activities for GCP requirements
- Be familiar with assigned study timelines and communicate potential issues to study management
How will you get there?
- Works independently under direct supervision from Manager or Mentor
- 0 to 2 years work experience as a regional CRA; 3 years direct clinical research experience or ophthalmology clinic experience
- Bachelor's degree in biological science, health science, nursing, health related area, or equivalent clinical experience required
- Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels of a CRA
- 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 70%, including overnight, domestic and international
- Must have Self-directed behavior
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.
Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we’re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Check out our profile on The Muse to get an inside look at our company culture. Glaukos Corporation has been Certified as a Great Place to Work the last two years!
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
