Clinical Research Associate

Description

• Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects; May co-ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
• Travels to field sites to monitor studies.
• Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
• Works with Data Management and Biostatistical staff on the design of documents and processes for the collection of study data from participating sites.
• Ensures site compliance with the study protocol, FDA regulations, ICH Guidelines and Good Clinical Practice (GCP)
• Uses discretion and independent judgement to recommend solutions to basic problems that the individual or team projects.
• Knows and effectively uses the broad concepts of a particular field or specialization to resolve problems of limited scope and complexity.

• B.S. or M.S. in Biology, Chemistry, Molecular Biology or related discipline.
• Requires 4-6 years relevant clinical research experience
• **The candidate must be an extremely detail oriented "people person", a self starter with excellent lab skills. He or she must be able to work in a team situation, have the ability to solve problems in a detailed, comprehensive manner, demonstrate urgency and energy to handle problems, meet timelines and manage sites. He or she must have excellent written and verbal communication skills, and good presentation skills. Additionally, MSWord, Excel, and Powerpoint skills are required.