Clinical Research Associate II

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Job Description

Independently Provide Site Management & Monitoring support for BDPI clinical studies to enable successful completion of study objectives and deliverables.

Ensure quality and compliance for assigned clinical studies and study activities performed at assigned clinical sites, ensuring the highest standards for scientific quality, integrity and ethics are met and that these are conducted in accordance with BD global clinical procedures, study protocols, GCP and all applicable regulations.

Demonstrates

Required:

Knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP/ICH), ISO
14155 and current industry practices related to the conduct of clinical studies.

Independently Conduct on-site or remote clinical site monitoring activities for assigned clinical sites to evaluate sites for qualification or activation, review informed consent forms, review subject data for accuracy, issue and address data queries, ensure study is conducted compliantly, address/escalate study non-compliance issues, verify that any corrective actions are implemented, perform investigational clinical product accountability, ensure proper regulatory approval, review essential clinical study documents for completion/accuracy, conduct study training/presentations, ensure proper training documentation, ensure timely reporting for reportable events (e.g., Unanticipated Adverse Device Effects, device deficiencies, etc.),

ensure good documentation/clinical practices (GDP/GCP), ensure study supplies are adequate and perform other site management & monitoring activities, as needed.

Escalates & address non-compliance issues. Communicates and collaborates w/ study leadership.

Serve as a product, procedure and clinical study protocol resource for BD stakeholders, Investigators, and study site personnel. Develop and maintain strong relationships as the primary site contact.

Build strong partnerships with investigational site staff, hospital personnel, and cross-functional study teams to support study deliverables. Facilitate communication between clinical sites and BD stakeholders (e.g., PMs, Clinical Field Specialists, Contract Managers), as needed.

Develop and manage study-specific tracking reports to detail clinical study progress (e.g., screening/enrollment status, site activation status, SDV status, etc.), as needed, to ensure Site Management & Monitoring deliverables are completed compliantly, within study-specific timelines and within budgets for assigned clinical studies and/or sites.

Perform study and/or site-level audits of the Trial Master File (TMF) to ensure that study files are current, accurate, complete and audit-ready. Identifies, resolves, and escalates TMF quality issues and consistently achieves inspection readiness objectives.

Assist with study and site-level management of the Clinical Trial Management System (CTMS) to ensure that study and site details are current, accurate and complete.

Develop and/or complete study-specific Clinical Site Activation Checklists, Master Site Selection Trackers, Qualification Visit Reports, Initiation Visit Reports, Interim Monitoring Visit Reports, Close-Out Visit Reports, Confirmation & Follow-Up Letters, Clinical Site Product Accountability Logs,…