Sr. Clinical Research Associate (Remote)

OverviewJob Description SummaryThe Senior Clinical Research Associate is responsible for delivering high quality and compliant site management & monitoring 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 Senior Clinical Research Associate will be responsible for the day-to-day management and oversight of assigned clinical sites, performing on-site and remote monitoring visits, driving recruitment, providing technical/troubleshooting support and for developing strong relationships with clinical site personnel including Investigators, study coordinators, nurses and other site staff. The Senior Clinical Research Associate will also lead and/or support Clinical Project Management with other study development, study start-up, study conduct/maintenance and study close-out activities including the review and development of essential clinical study documents. This job description is intended as a summary of the primary responsibilities of 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. ResponsibilitiesProvide 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 according to BD global clinical procedures, study protocols, GCP and all applicable regulations. 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. Serve as a product, procedure and clinical study protocol expert and resource for BD stakeholders, Investigators, and study site personnel. Develop and maintain strong relationships 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 required, to ensure Site Management & Monitoring deliverables are completed compliantly, within study-specific timelines and within budgets for clinical studies and/or sites assigned. Perform study and/or site-level audits of the Trial Master File (TMF) for accuracy, that files are current, 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 and/or complete study-specific reports such as: 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. Review and provide input on the development of other essential 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 build mitigation strategies in collaboration with clinical trial leadership and other management. 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 collaborators, as needed. Identify performance issues and training opportunities and communicate with leadership, as needed. Education And ExperienceBachelor's Degree (BS/BA) in life sciences or equivalent combination of training and experience (MA/MS preferred) 5+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology) 4+ years of experience with site management & monitoring or managing clinical projects QualificationsKnowledge and SkillsStrong working 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 Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.) Proficient knowledge of clinical study processes and systems (eTMF, CTMS and CDMS) Strong interpersonal and communication/presentation (oral and written) skills Strong organizational skills, attention to detail, effective judgment and analytical skills Able to manage and delegate multiple tasks and prioritize importance of tasks/projects Ability to travel up to 60% (or more during peak times) Preferred Skills & ExperiencePrior experience with clinical studies related to peripheral vascular diseases, end-stage kidney disease and/or oncology Experience with medical device studies Proficiency with Veeva Vault CTMS, CDMS and eTMF Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, etc.) Physical DemandsWhile working in this role, 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 EnvironmentWhile performing the duties of this job, the employee may be in an open-cubicle environment. The 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. 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. NoteThis job description does not constitute an exhaustive list of duties or responsibilities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.#J-18808-Ljbffr