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

Principal Clinical Research Associate (Remote) - BD - Franklin Lakes, NJ - work from home job Company: BD Job 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 all applicable regulatory requirements and company policies and procedures. Job Description We are the makers of possible BD 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 all 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 believe that the human element, 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 lead 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. Perform all 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 BD-established standards. Prioritization of patient safety is maintained and informed consent procedures are carried out and documented properly. Make 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 BD standards. Maintain complete and audit-ready regulatory files for assigned site(s)/project(s) that align with company and industry parameters, e.g. ALCOA. 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. within company-specified quality standards. Support, as needed, regulatory submission activities. Collaborate actively with other GCA functions, e.g. DM, Statistics, Medical Affairs. Maintain all project supporting systems, e.g. CTMS, EDC, eTMF, etc. Coordinate, develop, and deliver site-facing presentation materials, Investigator Meetings, Initiation visits, etc. Make sure site staff are adequately trained in all project-related requirements and tasks. Participate in audit activities, as appropriate. Proactively identify, call out, and lead risks and issues to ensure compliance. Communicate internally and externally to ensure adequate knowledge sharing and operational continuity. Give to continuous 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, pathways, etc. May act in a Lead CRA capacity. 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 related field. Consideration of a candidate with any alternate level of education will be case-dependent based on experience and positional need 2+ 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 development Ability 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 delivery Technical 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 mindset. Demonstrated ability to prioritize multiple tasks with challenging timelines and results For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD 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 place 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 BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit Becton, 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 origin, ancestry, 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-PRO Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift NA (United States of America) Principal Clinical Research Associate (Remote) - BD - Franklin Lakes, NJ - work from home job Expected salary: Location: Franklin Lakes, NJ Principal Clinical Research Associate (Remote) - BD - Franklin Lakes, NJ - work from home job Job date: Fri, 08 Sep 2023 23:46:53 GMT Apply for the job now! Principal Clinical Research Associate (Remote) - BD - Franklin Lakes, NJ - work from home job Apply tot his job