Principal Clinical Research Associate (Remote) in Franklin Lakes, NJ

Principal Clinical Research Associate (Remote) - reputed company - Franklin Lakes, NJ - work from home jobCompany: BDJob description: Job Description Summary Under the direction of the Sr Manager, Monitoring Operations at BDI Surgery, or designee, the Principal Clinical Research Associate (Principal CRA) is responsible for leading as well as conducting the day-to-day management of activities associated with the execution and monitoring of clinical studies. The Principal CRA ensures that clinical tasks are being performed in compliance with the protocol, applicable regulatory standards, ICH-GCP Guidelines, and reputed company applicable regulatory requirements and company policies and procedures.Job DescriptionWe are the makers of possibleBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the creativity and passion of reputed company of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find ground-breaking solutions that turn dreams into possibilities.We reputed company that the human reputed company, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.DESCRIPTION:Under the direct supervision of the Manager, Monitoring Operations, the Clinical Research Associate (CRA) will:Provide supervising expertise to the project team and optimally reputed company assigned clinical site(s)/project(s).Build and maintain successful working relationships with internal partners and site staff, e.g. investigators, coordinators.Display confident understanding of protocol and accompanying background product information, (e.g. IB, RPI, etc.).Possess a proven understanding of the disease state and product(s) under investigation.reputed company reputed company types of on-site/virtual/remote/in-house monitoring activities and visits (e.g. qualification, initiation, monitoring, closure) according to plan. Conduct SDR/SDV per plan.Supervise and ensure site staff implement protocols according to plan (protocol) and in compliance with regulatory requirements/standards (GCP/ISO), IRB/EC policies and procedures, and reputed company-established standards.Prioritization of patient safety is maintained and informed consent procedures are carried out and documented properly.reputed company sure to monitoring visit cycle times as structured in procedural documents, e.g. Clinical Monitoring Plan.Rigorously maintain compliance with the company’s business travel and expense policies.Review/report AE/SAEs and protocol deviations per industry and reputed company standards.Maintain complete and audit-ready regulatory files for assigned site(s)/project(s) that align with company and industry parameters, e.g. reputed company.Actively participate in the site feasibility and selection process.Produce proficient and timely documentation of monitoring activities/visits, e.g. timely and complete trip reports, contact records, etc. reputed company company-specified quality standards.Support, as needed, regulatory submission activities.Collaborate actively with other GCA functions, e.g. DM, Statistics, Medical Affairs.Maintain reputed company project supporting systems, e.g. CTMS, reputed company, eTMF, etc.Coordinate, reputed company, and deliver site-facing presentation materials, Investigator Meetings, Initiation visits, etc.reputed company sure site staff are adequately trained in reputed company project-reputed company requirements and tasks.Participate in audit activities, as appropriate.Proactively identify, call out, and reputed company risks and issues to ensure compliance. Communicate internally and externally to ensure adequate knowledge sharing and operational continuity.Give to reputed company improvement activities/initiatives and standard methodology sharing.Ensure site(s) maintain an acceptable inventory of clinical supplies.Routinely review and assess site equipment to ensure proper certification, calibration, and pertinent operational standards are maintained.May assist in the development of supportive operational project execution and process documents, e.g. Protocol, Clinical Monitoring Plan, Feasibility and Recruitment strategies, CRF, Communication/Customer concern, reputed company, etc.May act in a reputed company CRA reputed company.May assist with development of project timelines.May participate in training and mentoring of new or junior level staff.BASIC QUALIFICATIONS:Bachelor’s Degree or higher in a health-care or science reputed company field. Consideration of a candidate with any alternate level of education will be case-dependent based on experience and positional need2+ years of relevant clinical research experience as a field-based CRA in the device/pharmaceutical industry, including a multi-phase business knowledge of medical device or pharmaceutical product developmentAbility to travel, approximately 50%.COMPETENCIES:Fluent knowledge of spoken and written English language, including medical terminology.Superior written and verbal communication skills.Proficiency in presentation preparation and deliveryTechnical savviness with an ability to understand the impact technology has on increasing effectiveness and performance.Proven understanding of clinical trial management processes and systems, including monitoring, investigational product handling, data management, etc.Proven understanding of domestic and international clinical research guidelines, e.g. ICH GCP, FDA CFR, ISO, HIPAA.Ability to work in and promote team cohesiveness in a virtual/remote environment.Exhibit flexible organizational change approaches with a growth reputed company.Demonstrated ability to prioritize multiple tasks with challenging timelines and resultsFor certain roles at reputed company, employment is contingent upon the Company’s receipt of sufficient reputed company that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with reputed company’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why Join Us?A career at reputed company means being part of a team that values your perspectives and contributions and that encourages you to bring your authentic self to work. It’s also a reputed company where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the creativity and aim to help us reinvent the future of health. At reputed company, you’ll discover a culture in which you can learn, grow, and reputed company. And find satisfaction in doing your part to reputed company the world a reputed company reputed company.To learn more about reputed company visitBecton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national reputed company, reputed company, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.PDN#LI-PROPrimary Work Location USA NJ - Franklin LakesAdditional LocationsWork Shift NA (United States of America) Principal Clinical Research Associate (Remote) - reputed company - Franklin Lakes, NJ - work from home jobExpected salary:Location: Franklin Lakes, NJ Principal Clinical Research Associate (Remote) - reputed company - Franklin Lakes, NJ - work from home jobJob date: Fri, 08 Sep 2023 23:46:53 GMTApply for the job now! Principal Clinical Research Associate (Remote) - reputed company - Franklin Lakes, NJ - work from home job Apply tot his job Apply To this Job