The CRS II will assist in designing, planning and conducting high quality clinical research trials or data registries to ensure safety and effectiveness of Abiomed products.
Job Responsibilities:
Conduct periodic monitoring activities with investigative sites, including reviewing case report forms (CRF's), performing source document verification, monitoring compliance with good clinical practice (GCP) guidelines and FDA regulations, and monitoring device accountability
Conduct site initiation and study closeout activities
Prepare, modify and distribute study materials such as CRF's, study reference manuals, and monitoring guidelines/manuals
Provide training to site personnel
Participate in investigator meetings.
Negotiate budget, contract, and IRB/EC approval with sites and investigators.
Assist with the preparation of FDA submissions
Other responsibilities as assigned
Skills/Requirements
Experience:
Bachelor's or higher degree mandatory
2 -5 years of clinical research specialist experience
Experience in Class III cardiovascular device studies preferred
Ability to work on multiple protocols at the same time
Strong working knowledge of guidelines, systems for clinical trial management and of ICH, FDA, and GCP regulations and practices
Proven track record of having good investigator and site relations
Excellent interpersonal, verbal, and written communication skills
Attention to detail and strong organizational skills
Strong knowledge of Microsoft Office Suite and Outlook
