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Job #02389

About our client Our client is a newly created biopharmaceutical company dedicated to bringing best-in-class critical care and hospital-based therapeutics to patients. The company’s strategy is to acquire clinical stage or marketed drugs and develop them for markets with clear unmet medical needs. Position Location Clinical Research Associate Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the initiation, progress and conduct of the clinical trial 2) Ensure the scientific integrity of the data collected, and the protect the rights, safety and well being of human study subjects 3) Manage and monitor approximately 6 sites locally (MA, NH, RI, CT) every 6-8 weeks 4) Ensure compliance with protocol and overall clinical objectives 5) Perform study drug accountability 6) Ensure that the physician adheres to Good Clinical Practices and the study protocol 7) Verify the documentation of the informed consent process for each study subject 8) Ensure that non-serious and serious adverse experiences are properly documented and reported 9) Review case report form against the subject's medical record for completeness and accuracy 10) Ensure the filing and maintenance of the required regulatory documents 11) Perform clinical trial and site management when in-house 12) Ensure the successful and timely completion of the ART-123 Phase 2b clinical trials Requirements 1) BS, RN or BSN degree or equivalent 2) 3+ years of experience in the field or in a related area 3) Knowledge of FDA regulatory requirements 4) Demonstrated experience in a pharmaceutical company, contract research organization, academic institution or site management organization