Clinical Project Coordinator

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 Job Summary:   The Clinical Project Coordinator is responsible for delivering high quality and compliant support for clinical studies (e.g., EFS/FIH, IDE, Post-Market) sponsored by the BD Peripheral Intervention business unit to ensure they meet the highest standards for scientific quality, integrity and ethics and are conducted in accordance with BD global clinical procedures, study protocols, GCP and all applicable regulations. The Clinical Project Coordinator will   be responsible for   the day-to-day operational support of assigned clinical studies, management of study supplies and investigational   devices   and administrative support for the Clinical Affairs team. The Clinical Project Coordinator may also support the review and development of essential clinical study documents.   This job description is intended as a summary of the primary   responsibilities   and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be   required   either now or in the future.   Job Responsibilities:   (Primary Duties, Roles, and/or Authorities)   Under direct manager supervision (or supervision of other Clinical Affairs personnel), the Clinical Project Coordinator will:   Provide operational support for BDPI clinical studies to enable successful completion of study   objectives   and deliverables.     Ensure quality and compliance for activities performed for assigned clinical studies 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.    Prepare and ship clinical study supplies (e.g., study binders, mini protocols, etc.) and investigational products from BD Peripheral Intervention’s headquarters to domestic and international locations for assigned clinical studies.   Manage inventory and accountability of clinical study supplies and investigational products.   Serve as a Clinical Product Management expert and resource for BD stakeholders, Investigators, and study site personnel.     Support annual Sunshine Reporting activities and track transfers of value for clinical study supplies and investigational products, as appropriate.   Support Clinical Project Management and/or Site Management & Monitoring with other administrative tasks (e.g., collection & upload of study documents, Confidentiality Disclosure Agreement requests, Clinical Study Agreement requests, clinical study registration updates, Purchase Order Requests, etc.) as needed, to facilitate the conduct of the study.   Assist with Trial Master File (TMF) maintenance and perform study and/or site-level audits to ensure that study files are current,   accurate ,   complete   and audit-ready.   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, complete and/or manage study-specific Clinical Product Management Plans, Clinical Product Forecasting & Tracking Templates, Clinical Site Product Accountability Logs, Clinical Product Assembly Forms, Clinical Product Inspection Forms, Clinical Product Shipment Request Forms, Clinical Site Product Receipt Confirmations, Clinical Site Product Return Records, Clinical Site Product Destruction Records, Requests for Clinical Supplier Contract Forms, Debarment Checks and other essential clinical study documents, as needed.   Review and provide input, as needed, on the development of other essential clinical study documents related to Clinical Project Management, Site Management & Monitoring, Clinical Data Management, Clinical Statistics, Clinical Safety Management, Clinical Product Management and Clinical Supplier Management.   Perform general administrative functions for   Clinical   Affairs team (e.g., new hire onboarding tasks, IT requests, office supply orders, etc.), as needed.   Develop and   maintain   strong relationships with investigational site staff and study teams to support study deliverables. Facilitate communication between clinical sites and BD stakeholders (e.g., Clinical Project Managers, Clinical Research Associates), as needed.     Communicate BD product complaints and other events/issues that inhibit safe and effective use of BD products and negatively   impact   data integrity and study performance to BD stakeholders   in accordance with   established clinical study procedures and company policies.     Participate in and/or support study-specific meetings including, but not limited to study team meetings, Clinical Product Management meetings, and vendor meetings.   Provide critical thinking and support for   issue   escalation related to Clinical Product Management. 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 Clinical Product Management activities.   Support continuous improvement activities/initiatives and sharing of best practices, including development of Clinical Product Management tools and resources.   Support processi