# Job Description Summary# Job DescriptionThe Sr\. Clinical Research Associate \(Sr\. CRA\) is responsible for directing the day\-to day management operations associated with the execution of clinical trials\. The Sr\. CRA ensures that clinical tasks are being performed in accordance with the study protocol, BD procedures and SOPs, ICH\-GCP Guidelines, and all applicable regulatory requirements\.The Sr\. CRA will also be assigned to monitor at investigative sites on as needed basis\. Under the direction of the Project Manager the Sr\. CRA may be assigned as the primary vendor contact, and may be delegated other study related tasks and functions\.**Essential Job Functions:**In conjunction with the Project Manager the Sr\. CRA will:1\. Support the development of the study protocol/case report forms, investigators brochure, clinical instructions for use, clinical reports and study documents;2\. Create and maintain clinical project documents, including project plans, monitoring guidelines and plans, data management plans, study manuals, monitoring visit reports, letter templates and study presentations;3\. Interacts with investigative sites, vendors and other functional areas as primary project contact for clinical issues;4\. Conduct on\-site clinical monitoring/quality activities to:+ Ensure that clinical staff assigned to specific clinical research projects complete tasks in accordance with the project agreements, BDprocedures and applicable regulations \(ICH\-GCP, HIPAA, CFR, ISO\);+ Document and report non\-compliance in a timely manner;+ Ensure that all clinical events are reported appropriately;+ Conduct investigational product accountability, subject screening/enrollment assessments, case report form monitoring/retrieval, and query resolution and ensure compliance with core lab requirements and submission of data for analysis\.5\. Mentors less experienced CRAs6\. Provides regular clinical status update information to team members and the Project Manager, including:+ Case Report Form \(CRF\) Completion status+ Source Document Verification \(SDV\) status+ Site Start\-up / Site Initiation Visit \(SIV\) status+ Enrollment Updates / Reports+ Core Lab \(or other vendor\) updates7\. Recommend and implement enhancements to clinical systems, guidelines, and processes;8\. Review work produced by the clinical team; \(monitor visit reports, correspondence, tracking reports, etc\)9\. Evaluate metric data to identify process improvements;10\. Coordinate and review clinical tasks;11\. Ensure that the monitoring team receives appropriate project and therapeutic training; Assists in the development and implementation of standardized processes and procedures for conducting clinical research**Basic Qualifications:**+ Prior experience leading professional staff in a clinical research environment preferred+ Strong computer skills including experiences with CTMS, EDC and eTMF systems+ Excellent communication skills \(oral and written\)+ Strong attention to detail+ Strong interpersonal and organizational skills+ Ability to work independently, manage multiple tasks and personnel in a fast paced environment+ Ability to travel up to 40%**Additional Desirable Qualifications Skills and Knowledge:**+ Medical device clinical trial experience**Education and/or Experience:**+ BA/BS in Health Science Field or RN/BSN degree or equivalent combination of training and experience+ A minimum of 5 years experience monitoring and managing investigational sites+ Proficient knowledge of FDA regulations regarding device research and development is required**Physical Demands:**While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment\. The employee frequently is required to talk and hear\.The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch\.Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer\. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status\.\#LI\-PRO# Primary Work LocationUSA AZ \- Tempe Headquarters# Additional Locations# Work ShiftBecton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.