PRINCIPAL CLINICAL RESEARCH ASSOCIATE
Company: Shockwave Medical
Location: Saint Paul
Posted on: October 22, 2024
Job Description:
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Shockwave Medical, Inc. is a pioneer in the development and
commercialization of Intravascular Lithotripsy (IVL) to treat
complex calcified cardiovascular disease. Shockwave Medical aims to
establish a new standard of care for medical device treatment of
atherosclerotic cardiovascular disease through its differentiated
and proprietary local delivery of sonic pressure waves for the
treatment of calcified plaque.
Position OverviewThe Principal Clinical Research Associate (CRA) is
responsible for the day-to-day management of a global clinical
study. The Principal CRA will be accountable for project management
activities, oversight of multiple vendors and for conducting a
global clinical study in compliance with applicable clinical and
regulatory standards and in alignment with the business needs. The
individual is a subject matter expert in clinical research and this
work is accomplished with minimal oversight, requires frequent
contact with internal and external customers and is critical to the
success of the business.
Essential Job Functions
- Responsible for organizing, communicating and evaluating team
objectives for clinical studies.
- Participates in study design and study preparation activities,
as applicable.
- Develops and revises clinical trial documentation including
clinical trial protocol development, case report form (CRF)
development, IRB/Ethics submissions.
- Participates or leads the process to evaluate and select
potential investigators and sites.
- Participates or leads the process to evaluate and select
potential vendors as applicable.
- Conducts or oversees site visits as required (pre-study,
initiation, interim and close-out visits) to ensure protocol
compliance, accurate and thorough data collection, and appropriate
study conduct.
- Develops and revises site training tools, interprets clinical
data, manages investigational sites, develops tracking tools and
performs other clinical activities as needed during clinical study
conduct.
- Leads clinical study teams focused on conducting clinical
programs consistent with applicable regulations, guidelines, and
policies.
- Manages project timelines and vendor performance to meet
departmental and corporate goals.
- Monitors and tracks clinical trial progress and provides status
update reports.
- Manages study budget, payment process and reconciliation of
invoices for all clinical trial vendors including investigative
sites when applicable.
- Oversees work produced by junior clinical team members.
- Manages all clinical trial vendors (e.g., IRB, IVRS,
central/core labs, such as angiogram, ultrasound, or central
ECG).
- Analyzes and evaluates clinical data gathered during
research.
- Leads, prepares and reviews project and study-related documents
including: informed consent forms, investigational brochures, case
report forms, monitoring plans, synopses, protocols and amendments,
and other appropriate sections for studies conducted under
Investigational Device Exemption (IDE) or 510(k) application.
- Responsible for authoring internal documents and clinical study
reports and assisting with clinical evaluation reports.
- Develops and revises annual, interim, and final reports and
clinical sections of Pre- or Post-Market Approval submissions.
- Coordinates the design, format and content of CRFs, study
guides, study reference binders, and forms including participating
in the EDC and IVRS specification process and UAT.
- Coordinates and manages Investigational Product including
overall accountability and reconciliation.
- Responsible for selection of CRO study staff and coordinating
training including documentation.
- Leads the review of clinical data at the CRF, data listing, and
report table levels.
- Represents Clinical Affairs at the Project Team level for
individual studies, as appropriate.
- Identifies and escalates site, vendor and study related issues
to supervisor, as appropriate.
- Oversees clinical and adverse event data evaluation during the
conduct of the study and for completion of clinical study reports.
Working knowledge of CEC and DSMBs.
- Manages training of investigators, site staff, and SWMI
clinical staff.
- Oversees quality by maintaining compliance, reviewing device
complaints, reviewing audit reports and implementing corrective and
preventative actions.
- Other duties as assigned.
Requirements
- Bachelor's Degree or equivalent experience in a scientific
field of study.
- Minimum 10 years' experience directly supporting clinical
research or relevant experience in medical/scientific area. Minimum
1 year in a role directly managing trials and projects, 2-3 years
preferred.
- Ability to travel 10-20% domestically and internationally.
- Thorough knowledge of Good Clinical Practice (GCP) is
required.
- Working knowledge of GCP, FDA, ISO and other applicable
regulations.
- Experience with EDC Data Management Systems.
- Basic understanding of peripheral and coronary artery disease
and therapies preferred.
- Knowledge and experience in supporting device pre- and/or
post-market clinical studies is required including experience
running IDE trials.
- ACRP or SOCRA clinical research certification preferred.
- Able to manage multiple project teams.
- Ability to work in a fast-paced environment while managing
multiple priorities.
- Operate as a team and/or independently while demonstrating
flexibility to changing requirements.
- Must have excellent verbal and written communication
skills.
- High attention to detail and accuracy.
San Francisco Bay Area (SFBA) Market Range: $121,000 - $151,000All
Other US Locations (Outside of SFBA): $102,000 - $130,000
Exact compensation may vary based on skills, experience, and
location.
BenefitsShockwave Medical offers a competitive total compensation
package as well as the following benefits and perks:
Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k
options with a fully vested match, Short-Term and Long-Term
Disability, and Life Insurance, Employer contribution toward Health
Savings Account (HSA), Competitive PTO balance.
Perks: Calm App, Pet Insurance, Student Loan Refinancing, Spot
Bonus awards.
EEO Employer
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Keywords: Shockwave Medical, Maple Grove , PRINCIPAL CLINICAL RESEARCH ASSOCIATE, Accounting, Auditing , Saint Paul, Minnesota
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