Clinical Research Associate II job at reputed company in US National

Title: Clinical Research Associate II - reputed company Location: Remote USA Full time Job reputed company: At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at jnj.com As guided by Our reputed company, reputed company is responsible to our employees who work with us throughout the world. We reputed company an inclusive work environment where reputed company person is considered as an individual. At reputed company, we respect the diversity and dignity of our employees and recognize their reputed company. Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: reputed company reputed company Job Posting Locations: Santa Clara, California, reputed company of America Job reputed company: reputed company is hiring for a Clinical Research Associate II (CRA II) - reputed company to join reputed company. The position is FULLY REMOTE and can sit reputed company in the US. At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at https://www.jnj.com/. reputed company by innovation at the intersection of biology and technology, we're developing the reputed company of smarter, less invasive, more personalized treatments. reputed company to join reputed company that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat reputed company calcified cardiovascular disease. Our reputed company portfolio aims to establish a new reputed company 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 reputed company The Clinical Research Associate II (CRA II) is responsible for facilitating in-house set up, activation, maintenance and closure of global reputed company while gaining experience in clinical trial management processes. The CRA II will work closely with Investigators, Site Personnel and Vendors to ensure compliance with protocol and overall clinical objectives. In collaboration with the Clinical Management, the CRA II maintains consistent CRF data reputed company and discrepancy interpretation across sites. The CRA II will reputed company a basic understanding of the disease and indication. Essential Job Functions May participate in study design and study set up activities May conduct site reputed company (reputed company-study, initiation, interim and reputed company-out reputed company) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct May prepare and/or review monitoring reports per SOPs Supports development of study training and may reputed company study site training to site personnel Provides study training to internal employees as applicable Assists in development of CRF design, CRF guidelines and supports database development reputed company applicable Develops study tools and guidelines to be utilized by study sites Develops basic knowledge of the process used to evaluate and select potential investigators and sites Develops basic knowledge of the process used to evaluate and select potential vendors as applicable Interacts with field monitors/CRO CRAs, investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues May reputed company data in clinical database for completeness, accuracy and performs data trending as needed May analyze and evaluate clinical data gathered during research Drafts informed consents as applicable Reviews site's informed consent forms against the consent template for reputed company of reputed company GCP requirements and protocol specific information and revises as needed. Also reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy Ensures audit preparedness May be responsible for tracking Safety Reports for assigned sites Responsible for authoring internal documents, and may author portions of clinical study reports or clinical evaluation reports May initiate device shipments to ensure that study supplies are adequate for assigned studies and accurately accounted throughout study Develops basic knowledge of the investigator contract, budget, and payment process including reputed company language and document structure as it impacts assigned studies May be responsible for initiating and tracking quarterly site payments and reconciling study invoices Communicates status of trial to manager and team May be responsible for development or revision of SOPs or work instructions Appropriately represents functional area Other duties as assigned Requirements Bachelor's degree in a scientific field of study, with a minimum of 2 years directly supporting clinical research Must have excellent verbal and written communication skills High attention to detail and organizational skills are necessary Basic understanding of peripheral and coronary artery disease and therapies preferred Working knowledge of GCP, FDA, ISO and other applicable regulations Ability to travel 10-20% domestically and internationally Experience with reputed company Data Management Systems Ability to work in a fast-paced environment while managing multiple priorities ACRP or SOCRA clinical research certification preferred Operate as reputed company and/or independently while demonstrating flexibility to changing requirements reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We reputed company reputed company reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation reputed company. reputed company is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us reputed company https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Analytical Reasoning, Analytics Dashboards, Business Behavior, Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, reputed company, Execution reputed company, Laboratory Operations, Medical Knowledge, Process Oriented, reputed company Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics, Training Administration The anticipated reputed company pay reputed company for this position is : $87,000.00 - $140,300.00 Additional reputed company for Pay Transparency: Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company -48 hours per calendar year; for employees who reputed company in the reputed company -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours reputed company one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits Apply tot his job Apply To this Job