Careers

To apply for the position below, email your résumé to Lisa Byrne at careers@artisanpharma.net. Emails only, please.

 

Clinical Research Associate

Artisan Pharma is a newly created biopharmaceutical company dedicated to bringing best-in-class critical care and hospital-based therapeutics to patients. Artisan’s strategy is to acquire clinical stage or marketed drugs and develop them for markets with clear unmet medical needs.

Position Description:

The Clinical Research Associate will oversee the progress and conduct of the clinical trial under the direction of the Director of Clinical Operations. This position ensures compliance with protocol and overall clinical objectives to ensure the successful and timely completion of the ART-123 Phase 2b clinical trials and all related clinical trial milestones. This is an opportunity to work on a novel therapy and have an impact on the success of a trial while working with a small, dynamic, clinical group.

Responsibilities:
· Oversee the initiation, progress, and conduct of the clinical trial to ensure the scientific integrity of the data collected, and the protection of the rights, safety, and well-being of human study subjects
· Ensures compliance with protocol and overall clinical objectives
· Manage and monitor approximately 6 sites locally (MA, NH, RI, CT) every 6-8 weeks to ensure that the physician adheres to Good Clinical Practices and the study protocol
· Perform study drug accountability
· Verify the documentation of the informed consent process for each study subject
· Ensure that non-serious and serious adverse experiences are properly documented and reported
· Review the case report form against the subject's medical record for completeness and accuracy
· Ensure the filing and maintenance of the required regulatory documents
· Perform clinical trial and site management when in-house

Requirements:

· BS, RN or BSN degree or equivalent
· 3+ years of experience in the field or in a related area
· Knowledge of FDA regulatory requirements
· Increasingly responsible position with demonstrated experience with a pharmaceutical company, contract research organization, academic institution, or site management organization.

ART-123 is a novel, recombinant, soluble, human thrombomodulin being developed for the treatment of DIC (disseminated intravascular coagulation) in sepsis and DVT (deep vein thrombosis). ART-123 uniquely targets both coagulation and systemic inflammatory pathways and holds great promise as a self-regulating treatment of DIC in sepsis. Phase 3 studies have been completed for ART-123 in Japan for DIC and the product recently filed a Japanese NDA. Artisan plans on initiating Phase 2b studies of ART-123 for DIC in sepsis in the US early next year. Approximately 1.8 million patients in the United States and Europe suffer from sepsis annually, with approximately 30 percent of them developing DIC. For those that do, prognosis is poor.

For more information, visit our website: www.artisanpharma.net

Artisan Pharma is a Drug Free Workplace and pre hire drug screening will be preformed.