Clinical Research Associate - REMOTE
Company: Pentax Medical
Location: Montvale
Posted on: June 15, 2022
Job Description:
About PENTAX Medical Our mission is to improve the standard of
patient care and quality of healthcare delivery by providing the
best endoscopic products and services with a focus on QUALITY,
CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading
edge R&D and manufacturing, PENTAX Medical provides endoscopic
imaging devices and solutions to the global medical community.
Position Opening: CLINICAL RESEARCH ASSOCIATE Why JOIN Us? We are
an established medical device leader that is preparing for high
growth. This role will provide expertise in developing our
essential engineering projects.. PENTAX Medical is proud of its
comprehensive benefits program and generous Paid Time Off and
Holiday policy. Want More INFO? Our Clinical Research Associate are
critical to supporting our clinical studies (pre-market,
post-market, FDA regulated, PMCF, animal) to ensure that our
medical devices are the best at providing care to the
patients.Responsibilities of the Clinical Research Associate :
- Track study milestones and provide progress updates to
management
- Conduct routine monitoring visits
- Interface with site personnel to ensure the study protocol is
followed
- Regular review of the database to ensure accuracy of data
entered
- Create interim data slides for management and
investigators
- Ensure proper reporting of all AEs and protocol deviations
- Ensure complete, accurate and timely document collection and
proper maintenance of Study Master and Site Files throughout the
lifecycle of the clinical project(s)
- Identify and escalate potential issues and retraining
opportunities for site personnel
- Contribute to improve clinical department processes and
procedures, e.g. draft monitoring plans, study templates, SOPs,
study tracking tools, etc.
- Maintain ongoing compliance with the companys policies and
procedures (SOPs) and Quality System and FDA regulations, and all
applicable domestic and/or international requirements
- Participate in clinical department and investigators meetings,
as needed
- Assist in the preparation of CERs and Post Market Surveillance
activities for Technical Files
- Support regulatory effort where clinical input or clinical data
is needed Qualifications of the Clinical Research Associate :
- Bachelors Degree, preferably in life science, nursing/health
science or engineering
- 1-2 years of experience with scientific/clinical studies that
were subject to IRB or other ethical oversight
- Demonstrates sound knowledge of the scientific process, good
clinical practice
- Possesses sound interpersonal skills; flexible and willing to
adapt to changing situations
- Demonstrates written and verbal communication skills
- Ability to work independently using good judgment, initiative
and analytical abilities
- Organized and proficient at multi-tasking, with excellent
attention to detail
- Willing to travel up to 50% during time critical periods It is
the ongoing policy and practice of PENTAX Medical to provide equal
opportunity in employment to all employees and applicants. No
person shall be discriminated against in any condition of
employment because of age, color, disability, gender identity,
genetic information, military or veteran status, national origin,
race, religion, sex, sexual orientation or any other applicable
status protected by state or local law.
Keywords: Pentax Medical, Tenafly , Clinical Research Associate - REMOTE, Healthcare , Montvale, New Jersey
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