Under the direct supervision of the Project Manager, the CAA will:

Conduct site qualification visits and initiate investigational sites;

Conduct on-site monitoring of clinical studies to ensure compliance with the Investigational Plan and all applicable policies and regulations;

Ensure that all applicable documents are present in the master study file (in-house and on-site) and comply with Bard policies and procedures, ISO standards, Good Clinical Practices, and all applicable regulations;

Ensure that study data are complete, accurate, and verifiable;

Conduct investigational product accountability;

Serve as the primary sponsor contact for investigational sites;

Develop strategies to successfully drive site performance in meeting project objectives;

Assist in the development of study protocols, case report forms, and study documents;

Provide regular project status updates to the project management team;

Identify and assist in the implementation of enhancements to Bard's clinical research practices;

Track key study metrics and provide regular updates to the project team;

Document and report non-compliance issues in a timely manner;

Participate in regular project team meetings;

Assist in the training of Clinical Affairs Personnel.

BA/BS (MA/MS preferred) in health science field or equivalent combination of education and experience;     

While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.  The employee frequently is required to talk and hear.The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.