Clinical Research Associate (REMOTE)
Job Description Summary
REMOTE USA - Ideal geography West Coast or North
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Under the direct supervision of the Manager, Monitoring Operations, the Clinical Research Associate (CRA) will:
Provide monitoring expertise to the project team and effectively manage 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 accompany background product information, (e.g. IB, RPI, etc.).
Possess a working knowledge 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.
Oversee and ensure site staff execute protocols according to plan (protocol) and in compliance with regulatory requirements/standards (GCP/ISO), IRB/EC policies and procedures, and BD-established standards.
Prioritize patient safety is maintained and informed consent procedures are carried out and documented properly.
Adhere to monitoring visit cycle times as structed in procedural documents, e.g. Clinical Monitoring Plan.
Strictly 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 comply 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.
Ensure site staff are adequately trained in all project-related requirements and tasks.
Participate in audit activities, as appropriate.
Proactively identify, escalate, and manage risks and issues to ensure compliance.Communicate internally and externally to ensure adequate knowledge sharing and operational continuity.
Contribute to continuous improvement activities/initiatives and best practice 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/Escalation 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.
Bachelor’s Degree or higher in a health-care or science related discipline.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%
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
Working knowledge of clinical trial management processes and systems, including monitoring, investigational product handling, data management, etc.
Working knowledge of domestic and international clinical research guidelines, e.g. ICH GCP, FDA CFR, ISO, HIPPA
Ability to work in and promote team cohesiveness in a virtual/remote environment
Exhibit flexible change management approaches with a growth mindset
Demonstrated ability to prioritize multiple tasks with competing timelines and deliverables
Based on experience level, the CRA may be hired at the Senior or Principal level.The Senior CRA and Principal CRA retain the responsibilities and competencies of the CRA, including acting as an individual contributor.The Senior CRA and Principal CRA will not directly manage people, though may contribute in processes related to people management, under the direct supervision of the Manager, Monitoring Operations.
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 opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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.
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsUSA WA - Seattle
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ