Clinical Research Associate

Qualifications

The Clinical Research Associate (CRA) is responsible for planning, negotiating, conducting, monitoring, and reporting on clinical trials. The CRA is responsible for protocol development, site selection and qualification, preparing Informed Consent materials, contracting, training, site monitoring, and study document management. The CRA collaborates with data management and statistics groups to ensure accuracy and integrity of study data.

Responsibilities

• Responsible for planning, budgeting, executing, and monitoring clinical evaluations of BD products to support product development.
• Provide product development teams and other functions with technical and clinical expertise and support.
• Activities will be performed in accordance with international, federal and/or local regulations (FDA, ISO), Good Clinical Practices (GCPs), and compliance with corporate and local quality policies and procedures.
• Specific Responsibilities:
• Develop the study design and protocol(s)
• Screen, select, and qualify principal investigators and investigational sites
• Conduct negotiations of clinical site agreements and contracts
• Ensure the compliance to all human subject protection and privacy regulations, including developing Informed Consent materials
• Develop time schedules and budgets necessary to manage the clinical evaluations
• Coincide and plan availability of supplies and shipment of materials
• Train clinical evaluation participants in study products and procedures
• Monitor sites to assure that the Protocol is understood and followed
• Collect, review, analyze, and report data generated during clinical evaluations in a timely manner, through interactions with Clinical Database/Statistics
• Communicate results of data analysis to each clinical center, project teams and applicable functions within BD, and actively support the publication and presentation of results by investigators
• Support the reporting of performance data to regulatory authorities
• Absorb responsibility for occasional special departmental projects
• Anticipate 10% to 25% travel (primarily domestic; international travel a possibility)