Clinical Research Associate II

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), ISO14155 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, Clinical Site Training Logs, Clinical Site Visit Logs, Delegation of Authority Logs, Clinical Monitoring Plans, Financial Disclosure Forms and other essential clinical study documents, as needed.

Review and provide input on the development of other essential clinical study documents related to Clinical Project Management, Clinical Data Management, Clinical Statistics, Clinical Safety Management, Clinical Product Management and Clinical Supplier Management.

Proactively and critically examine ways to enhance overall clinical study performance and transfer clinical study knowledge and experience into meaningful input and feedback to cross-functional study team partners within Clinical Affairs. 

Communicate BD product complaints and other events/issues that inhibit safe and effective use of BD products and negatively impact subject recruitment, data collection and study performance to BD stakeholders in accordance with established clinical study procedures and company policies. 

Participate in, support and/or lead study-specific meetings including, but not limited to study team meetings, Clinical Research Associate team meetings, and vendor meetings.

Support Clinical Project Management with other administrative tasks, as needed, to facilitate the conduct of the study.

Provide critical thinking and support for issue escalation related to site management & monitoring. Interact with investigational sites, vendors, and other functional areas for issues, as needed. Proactively identify issues and create mitigation strategies in collaboration with Clinical Project Management and other leadership.

Provide support for internal or external audits/inspections and ensure resolution of audit/inspection findings related to site management & monitoring activities.

Support continuous improvement activities/initiatives and sharing of best practices, including development of site management & monitoring tools and resources.

Mentor Site Management & Monitoring personnel and conduct monitoring evaluations or co-monitoring visits with other Site Management & Monitoring personnel, as needed. Identify performance issues and training opportunities and communicate with Site Management & Monitoring leadership, as needed.