Senior Clinical Research Associate

Becton Dickinson Medical Devices•Milpitas, CA

11h

About The Position

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) a 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 MedTech 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. The Senior Clinical Research Associate (Sr. CRA) provides Site Management and Study Monitoring for moderate to complex clinical performance studies conducted by BD Biosciences. The Sr. CRA is responsible for handling site interactions, site training, regulatory document collection, enrollment tracking, and ensuring accuracy, completeness, and verifiable documentation. The Senior CRA manages multiple sites and studies in compliance with Good Clinical Practices (GCP), and applicable regulations. The Sr. CRA can be and function as Lead Monitor on complex studies, and mentor junior Study Monitor(s) or Clinical Research Associates (CRA). The Sr. CRA must have experience working cross-functionally and in matrixial organization. In collaboration with the Clinical Project Manager and Project team, the Sr. CRA: 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 study vendors and submission of data for analysis, when applicable. Prepare high-quality monitoring visit reports and other required documentation as per Monitoring Plan and within the applicable timelines. Ensures timely filing of essential documents in the Trial Master File. Prepares Open Action Items/Observations and conduct follow-up until resolution. Conducts regular reviews of the site performance to ensure compliance with the protocol, BD procedures, applicable regulations and standards (GCP, GDPR, HIPAA, CFR, ISO, IVDR). Ensures that all clinical adverse events, device deficiencies and protocol deviations are reported appropriately. Proactively identifies and raises critical compliance issues to the Clinical Project manager and document non-compliance in a timely manner within BD monitoring report. Develops and implements site corrective actions as needed to address any non-compliance issues collaboratively with the Clinical Project Manager. Maintains working knowledge of disease state(s), immunophenotype, study product(s), analysis tools and supports that the monitoring team receives appropriate project and training. Provides work direction and mentoring to internal and external team members as needed and may supervise/ coach junior team members. Contributes to internal training activities and other department improvement initiatives. Assists with Regulatory Agency/Organization’s inspections and audits.

Requirements

BS in healthcare or science related discipline. Combination of education and experience will be considered.
5+ years’ experience as Clinical Research Associate directly involved with site monitoring
Working knowledge of ICH Good Clinical Practices
Knowledge of BD instruments and reagents, as well as technical savviness with an ability to understand the impact new methods and technology risk and mitigations during the conduct of studies and monitoring visits.
Solid understanding and experience of clinical trial management processes and systems, including monitoring, performance evaluation/ investigational use only product handling, data management, etc.
Strong working knowledge of Good Clinical Practices (GCP), local regulations, relevant ISO standards and current industry practices related to the conduct of clinical trials and applicable local and regional regulations.
Experience with Ethics Review requirements per country and submission management until approval.
Previous experience with EDC, CTMS, and eTMF systems required
Demonstrated ability to work effectively on cross-functional teams
Excellent verbal and communication skills in native language and English
Strong computer skills and proficiency with MS Windows based applications.
Proficient in preparation and delivery of study materials and presentation.
Able to manage multiple tasks and prioritize importance of assigned tasks/projects
Ability to work independently successfully
Travel up to 60% (domestic and international).
Ability to lift or carry (or otherwise move) objects with a maximum lift of 25-30 lbs.
Frequent mobility required, involving walking, stooping, crouching, bending, and twisting.

Nice To Haves

Preferably 2+ years of experience with medical devices and/or diagnostic studies
Professional certification through one or more relevant associations is desirable (e.g., ACRP, SOCRA, RAPS).

Responsibilities

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 study vendors and submission of data for analysis, when applicable.
Prepare high-quality monitoring visit reports and other required documentation as per Monitoring Plan and within the applicable timelines.
Ensures timely filing of essential documents in the Trial Master File.
Prepares Open Action Items/Observations and conduct follow-up until resolution.
Conducts regular reviews of the site performance to ensure compliance with the protocol, BD procedures, applicable regulations and standards (GCP, GDPR, HIPAA, CFR, ISO, IVDR).
Ensures that all clinical adverse events, device deficiencies and protocol deviations are reported appropriately.
Proactively identifies and raises critical compliance issues to the Clinical Project manager and document non-compliance in a timely manner within BD monitoring report.
Develops and implements site corrective actions as needed to address any non-compliance issues collaboratively with the Clinical Project Manager.
Maintains working knowledge of disease state(s), immunophenotype, study product(s), analysis tools and supports that the monitoring team receives appropriate project and training.
Provides work direction and mentoring to internal and external team members as needed and may supervise/ coach junior team members.
Contributes to internal training activities and other department improvement initiatives.
Assists with Regulatory Agency/Organization’s inspections and audits.