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 processing and entry of clinical site payments/invoices within CTMS, as needed.

Education and Experience:

• Bachelor’s Degree (BS/BA) in life sciences or equivalent combination of training and experience (MA/MS preferred)

• 1+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology), with supply inventory management/shipment, or in a clinical setting

Knowledge and Skills:

Required Qualifications:

• Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)

• 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 Qualifications:

• 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: (if applicable)

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: (if applicable)

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.