Principal Clinical Trial Associate
Location: San Clemente
Posted on: June 12, 2021
How will you make an impact?
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.
What will you do?
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
- 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:
- Manages clinical study product, including inventory
projections, requests for shipping (including verification of
essential documents), and accountability
- Assists with site selection
- Project manages from study initiation through study closure,
including timeline development, milestone achievement, and budget
- Oversees site monitoring/management activities of assigned
CRAs, as applicable.
- 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
- Communicates with sites, including leading enrollment
teleconferences, organizing investigator meetings, and traveling to
sites as needed
- Negotiates budgets with sites, assists with site contract
execution, and administers grant payments.
- Assists with ClinicalTrials.gov as needed
CROs and other vendors:
- Assists with selection of vendors
- Assists with development of budgets and contracts with
- Manages vendors to ensure proper study execution
- 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
- 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
- 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
- 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
- Assists employees with developmental needs and provides
- Develops relationships with key opinion leaders and clinical
- Stays abreast of recent developments in ophthalmology and
attends ophthalmic congresses on a periodic basis.
How will you get there?
- Bachelor's Degree Required
- Minimum 4 years relevant work experience in the clinical
research industry, preferably with experience in
- 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
- Prior experience working on a drug-device combination IND trial
- Excellent project leadership skills, including CRA and vendor
management, and ability to meet milestones and manage
- Study auditing and site monitoring skills and ability to train
- Experience with negotiating and executing site and vendor
- 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
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
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 here are empowered with more diverse and enriching
challenges than 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
paid 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 has
been named one of the Top Workplaces by the Orange County Register
for the past 3 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.
Keywords: Glaukos, San Clemente , Principal Clinical Trial Associate, Other , San Clemente, California
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