Senior Clinical Research Associate

Job Description Summary

This position plays a key role in managing the day-to-day activities of clinical studies from initiation through close-out. The Senior Clinical Research Associate ensures that all site-level activities comply with applicable regulations, Good Clinical Practice, company standards and procedures. The role involves planning and conducting monitoring activities and visits, ensuring data quality, participant protection of privacy, safety, and compliance with current regulations and requirements, while also providing leadership and mentoring within the clinical research team.

You will be expected to travel around 40% of the time, nationally and occasional abroad travel.

Waters (formerly BD Biosciences) is a world leader in bringing innovative diagnostic and research tools to life science researchers, clinical researchers, laboratory professionals and clinicians who are involved in basic research, drug discovery and development, biopharmaceutical production and disease management. The BD Biosciences segment is focused on continually advancing the science and applications associated with cellular analysis.

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 imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative 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.

• Plans and delivers clinical studies optimally, ensuring that documentation related to site coordination and observation are completed and aligned with study specific timelines and within budget.
• Creates and handles study specific tracking reports to detail clinical study progress related to specimen/subject enrollment status, data collection, data cleaning and completion progress, adverse events documentation, and site payments.
• Participates or leads internal study team meetings/Contract Research Organization (CRO) team meetings and report on clinical study status to team members and the Medical Affairs Leadership teams. Study status reporting includes analysis of data to identify trends and propose corrective actions, if required.
• Collaborates cross-functionally on the preparation of Feasibility questionnaires, and documentation related to site management and monitoring e.g. Clinical Monitoring Plan, monitoring tools, adjustment of study logs and forms etc.
• Supports during Database development by providing input into the eCRF design and performing User Acceptance Testing on created CRF pages, reviewing the Data Management Plan and providing input to the CRF completion guidelines.
• Acts as project contact for suppliers and/or other functional areas for clinical issues.
• Assists in planning, preparing, and communicating materials for Investigator and Study Staff meetings and training, when applicable.
• Performs on-site and/or remote site visits to conduct site selection, qualification and monitoring visits (Initiation, routine monitoring and close out visits). Participates in Site Qualification and Initiation activities, including training of Investigators and Study Coordinators. Also, re-trains Investigators and Study Coordinators, as needed.
• Acts as site manager by being the main point of contact for the site staff and ensuring that the clinical site staff is kept informed about the study and completes their study related tasks according to the study protocol.
• Conducts investigational product accountability, specimen/ subject eligibility, enrollment assessments, on-site or remote Case Report Form (CRF) monitoring and verification against source data, source document review (SDR) and promotes query resolution, ensure compliance with Lab requirements or other third-party…