Senior Clinical Research Associate (Oncology, Transplantation, Immunology)

Our client is a biopharmaceutical company dedicated to the development, manufacturing, and commercialization of medicines for patients with cancer and other life-threatening conditions. Our client has four marketed products and others in various stages of development and is seeking a Senior Level Clinical Research Associate.

In this very important position, the individual will be responsible for:In-house and Field Site Monitoring of Clinical Trial Investigational Sites to ensure Study Protocol compliance in adherence to GCP/ICH guidelines. Communication with Sites to ensure Study procedures are followed, to collect essential Trial information, to address and resolve Study-related issues. Maintaining accurate Study data to track enrollment, Study supplies and Milestone Payments. Conducting Pre-Study site initiation, interim monitoring and Site close-out visits with resulting visit reports. Ensuring Study data and Drug Accountability records are accurate and verifiable. Collecting, maintaining and managing Study documents and files within Trial Master File. Maintaining Study-related information within Clinical Trial Management System. Supporting Clinical Project Manager with developing Study-specific documents and operational procedures related to all phases of conducting Clinical Studies from start-up to close-out. Assisting Clinical Project Manager with compiling Study data for reporting to cross-functional teams and senior management.

Our Client would like the following credentials/experience:Bachelors Degree required preferably in one of the Life Sciences or Nursing. A minimum of five years of Clinical Research experience with a minimum of 3-4 year's direct monitoring experience. Demonstrated knowledge of the Clinical Development process/GCPs/ICH guidelines. Knowledge in the following therapeutic areas: Oncology, Transplantation or Immunology. Computer literacy in, MS Word, MS Project and Excel. Effective communication (verbal and written) and organizational skills.
Excellent interpersonal skills.

The Individual Must be willing to travel up to 50% domestically.Interested/Qualified candidates, please send your complete CV/Resume in MS Word format to Wally Casola, wally@ultimatesolutions.com or call 201-909-3717 for more information.  All replies shall be kept in strict confidence.  Please visit our website at www.ultimatesolutions.com to read about our confidentiality policies.