Principal Clinical Trials Associate
Glaukos Corporation is an ophthalmic medical technology and pharmaceuticalcompany focused on the development and commercialization of novel surgicaldevices and sustained pharmaceutical therapies designed to transform thetreatment of glaucoma, one of the world’s leading causes of blindness.
The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS,in order to revolutionize the traditional glaucoma treatment and managementparadigm. Glaukos launched the iStent®, its first MIGS device, in the UnitedStates in 2012 and is leveraging its platform technology to build acomprehensive and proprietary portfolio of micro-scale injectable therapiesdesigned to address the complete range of glaucoma disease states andprogression.
The company’s second-generation MIGS device, the iStent inject®Trabecular Micro-Bypass System, was approved by the Food and DrugAdministration, or FDA in June 2018. The company believes the iStent inject,®measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device everapproved by the FDA.
In June 2015, Glaukos completed an initial public offeringand our shares are now traded on the New York Stock Exchange under theticker symbol “GKOS”. The company was founded in 1998 and is based in SanClemente, California.
The Principal Clinical Trials Associate, based in San Clemente, California is responsible for management of assigned clinical studies, assisting with the development and analysis of assigned studies, supervision of assigned department employees, and development of department processes.
Clinical Study Design:
· Assists with development and writing of study protocols. Ensures protocols are in compliance with appropriate regulatory requirements and clinical operation written procedures.
· Assists in writing and/or compiling of data for clinical sections of IND or NDA applications.
· Assists with development and writing of the Clinical Investigator’s Brochure.
· Responsible for the development of the study Case Report Forms and associated data collection documents.
· Responsible for the development of the Informed Consent Form template, ensuring all regulatory requirements are addressed.
· Responsible for the development of the study Monitoring Plan, patient recruitment materials, and all other study documents.
· Assists with development of clinical study site budget.
Clinical Study Execution:
· Develops training documents for sites, team members, and surgeries. Train team members on clinical study requirements.
· Assists with project planning, problem resolution, and investigator meetings as needed.
· Provides proactive leadership in identifying enrollment issues and recommending solutions so that enrollment targets are met.
· Oversees all aspects of clinical study execution:
1. Manages clinical study product, including inventory projections, requests for shipping (including verification of essential documents), and accountability
2. Assists with site selection
3. Project manages from study initiation through study closure, including timeline development, milestone achievement, and budget projections
4. Oversees site monitoring/management activities of assigned CRAs, as applicable.
5. Reviews adverse event data, surgical data, and clinical study product accountability and alerts Regulatory Affairs, Clinical management, and Medical Monitor as needed to ensure UADEs/SUSARs and potential product issues are properly reported
6. Communicates with sites, including leading enrollment teleconferences, organizing investigator meetings, and traveling to sites as needed
7. Negotiates budgets with sites, assists with site contract execution, and administers grant payments.
8. Assists with ClinicalTrials.gov as needed
· CROs and other vendors:
1. Assists with selection of vendors
2. Assists with development of budgets and contracts with vendors
3. Manages vendors to ensure proper study execution
4. Communicates with vendors as main study contact
Clinical Study Analysis:
· Assists with development of clinical study reports (communications/reports to regulatory bodies, DSMB meetings, interim and final reports)
· Participates in the preparation of regulatory submissions as needed.
· Submits reports to IRBs as required.
· Develops metrics on study progress (e.g., enrollment, collection of CRFs, resolution of DCFs, etc.) overall, and by site. Provides progress reports to management, and recommends improvements to recruitment, study quality, data collection, and communication processes.
· Assists with investigator meetings at glaucoma-related conferences as needed.
· Clinical Process Development:
· Responsible for process development within the clinical department in order to ensure quality, effective, and efficient clinical operations:
· Writes SOPs and associated documents or reviews documents written by other department employees
· Develops processes to assess compliance with SOPs and study processes, including metrics
· Hires, trains, and supervises employees/contractors in order to ensure quality, effectiveness and productivity.
· Assigns projects with clear milestones and monitors progress to ensure timely completion.
· Provides supervisor of assigned team members with feedback on performance and assists with development through assigned study tasks.
· Assists employees with developmental needs and provides development opportunities
· Develops relationships with key opinion leaders and clinical investigators.
· Stays abreast of recent developments in ophthalmology and attends ophthalmic congresses on a periodic basis.
· Minimum 4 years relevant work experience in the clinical research industry, preferably with experience in ophthalmology.
· Pharmaceutical experience required.
· Clinical Supplies Management preferred.
· Budgeting experience preferred.
· Current, in-depth knowledge of applicable Good Clinical Practices (GCPs), ICH E6.
· Prior experience managing a US IND trial in Phases I, II or III and knowledge of pharmaceutical drug development processes.
· Working knowledge of drug Good Manufacturing Practices (CFR Parts 210 and 211) and how they impact clinical studies.
· Working knowledge of clinical pharmacology and drug terminology.
· Prior experience working on a drug-device combination IND trial highly desirable.
· Excellent project leadership skills, including CRA and vendor management, and ability to meet milestones and manage timelines
· Study auditing and site monitoring skills and ability to train CRAs
· Experience with negotiating and executing site and vendor budgets
· Experience with adverse event reporting and documentation
· Able to analyze and summarize study data, and assist with writing study reports
· Able to assist with study design and writing of protocols and all associated study documents
· Knowledge of clinical study product management and requirements for verifying accountability
· Experience with supervision of clinical employees
· Excellent problem solving skills
· Excellent written and verbal communication skills
· Self-motivated and able to work independently, as well as within a team
· Excellent organizational skills
· Experience with writing SOPs and process development/improvement to increase quality and efficiencies
· Must be willing and able to travel approximately 20%
· Medical and ophthalmology terminology helpful
· Exhibits personal integrity, credibility, and responsible
Bachelors Degree Required
We offer competitive salary (based on experience),bonus eligibility, medical/dental/vision, life insurance, stockoptions, 401(k) Employer Match, 3 weeks paid time off, 13 company paidholidays, Employee Stock Purchase Program and 2 additional paid days off tovolunteer in our community, plus the opportunity to work for a companythat is pioneering a new glaucoma treatment class. Check out our profileon The Muse toget an inside look at our company culture.
Glaukos Corporation is an Equal Opportunity/AffirmativeAction Employer. All qualified applicantswill receive consideration for employment without regard to race, color,religion, sex including sexual orientation and gender identity, nationalorigin, disability, protected Veteran Status, or any other characteristicprotected by applicable federal, state, or local law.