Clinical Research Associate

Position Clinical Research Associate Location Franklin Lakes, NJ Duration 12+ months contract Start Time

08:00 AM

End Time

05.00 PM

Total Hours/week 40.00 Pay Rate 45-60$/hr Responsibilities Responsible for planning, budgeting, executing, and monitoring clinical evaluations of BD products to support product development. Clinical evaluations may also be for post‑market surveillance studies, or claims extensions of existing products. 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. 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 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. Coordinate 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. Assumes responsibility for occasional special departmental projects. Anticipate 10% to 25% travel (primarily domestic; international travel a possibility). #J-18808-Ljbffr MillenniumSoft Inc