Clinical Project Coordinator

Job description

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 Descriptionof Responsibilities: 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 processing and entry of clinical site payments/invoices within CTMS, as needed. Minimum Requirements: Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.) Bachelors Degree in life sciences or equivalent combination of training or experience 1 year of clinical research experience (medical device, pharmaceutical, or biotechnology) Strong interpersonal and communication/presentation (oral and written) skills Strong organizational skills, attention to detail, critical thinking and analytical skills Able to manage and delegate multiple tasks and prioritize importance of tasks/projects Ability to travel up to 10% (or more during peak times) ​ Preferred Requirements: Knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies Knowledge of clinical study processes and systems (eTMF, CTMS and CDMS). Prior experience with Veeva Vault preferred. 1+ years of experience with similar role for a Sponsor or Contract Research Organization (CRO) Prior experience with clinical studies related to peripheral vascular diseases, end-stage kidney disease and/or oncology Experience with medical device studies Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, etc.) Physical Demands: While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. Work Environment: While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us?To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collabo