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