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Principal Clinical Research Associate

Remote, Sparks, MD

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Job ID: R-544580
Category: Medical / Clinical Affairs
Location: Sparks, Maryland

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose

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 imagination 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 transformative solutions that turn dreams into possibilities.

Job Description

Responsibilities

Study & Site Management

Serve as Lead CRA for assigned complex clinical studies, providing expert oversight of site selection, initiation, monitoring, and close‑out activities (on‑site, virtual, remote, and in‑house).
Actively participate in site feasibility assessments and site selection processes.
Ensure study conduct is executed according to the clinical protocol (CPSP), regulatory requirements (GCP, FDA, ISO), IRB/EC requirements, and company SOPs.
Prioritize patient safety, ensuring informed consent and study procedures are performed accurately and ethically.
Review and report AEs/SAEs and protocol deviations in accordance with regulatory and company requirements.
Maintain complete, accurate, and audit‑ready regulatory documentation and TMFs in accordance with ALCOA principles.
Monitor site inventory of investigational products and study supplies.
Proactively identify, communicate, and manage study risks and issues to ensure operational continuity and compliance.

Monitoring & Documentation

Author, review, and approve Monitoring Plans, study source documents, monitoring tools, and site‑facing training materials.
Perform SDR/SDV per monitoring plans and document monitoring activities through timely, high‑quality trip reports.
Ensure strict compliance with company travel and expense policies.

Leadership & Mentorship

Provide mentoring, training, and functional oversight of CRAs, including contingent (contract) CRAs.
Lead or review functional job aids and training materials.
Support interviewing, hiring, onboarding, and training of CRA staff.
Manage and oversee day‑to‑day activities of contingent CRAs, including approval of timecards and expense reports.
Present confidently and contribute to extended functional and study team meetings, providing clear updates on site status, risks, and issues.

Systems & Collaboration

Utilize and maintain accurate study data in clinical systems, including Veeva Vault CTMS and CDMS.
Work cross‑functionally with internal teams, CROs, and SMOs to ensure high‑quality study execution and oversight.
Build and maintain effective working relationships with investigator sites and internal stakeholders.

Qualifications

Education

Bachelor’s degree or higher in a healthcare or science‑related field.
Alternate education levels may be considered based on experience and business need.

Experience

Minimum of five (5) years of field‑based CRA experience in the medical device and/or pharmaceutical industry.
Experience across multiple phases of clinical research and product development.
Experience with IVD and/or POC studies strongly preferred.
Laboratory experience in molecular biology, microbiology, or blood culture is highly desirable.

Knowledge & Skills

Strong understanding of clinical trial operations, monitoring practices, investigational product management, and data management.
Thorough knowledge of domestic and international clinical research regulations, including ICH GCP, FDA CFR, ISO, and HIPAA.
Proficiency with Veeva Vault CTMS and CDMS required.
Excellent written and verbal English communication skills, including medical terminology.
Strong presentation, organizational, time‑management, and prioritization skills.
Technically savvy with the ability to leverage technology to drive efficiency and performance.
Ability to work independently with minimal supervision in a fast‑paced environment.

Why Join Us?

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 imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Required Skills

Optional Skills

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

NA (United States of America)

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

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