Clinical Research Monitor- Home/Field Based Position

We are an incubator/management firm focused on the medical technology, biotechnology, and healthcare fields. The Company?s principals have extensive experience in these fields as founders, early stage investors, major shareholders, and executives in the medical device and healthcare industries.  The unifying principle underlying these fields is the Company?s ability to leverage the medical and technical knowledge and experience of the people involved in its various ventures.  We have 9 portfolio companies in the US within our group at different stages of development. 

We are currently in search of an External Monitor for one of our portfolio companies located in Orangeburg, NY.  The company specializes in implantable medical devices for congestive heart failure.  The External Monitor will orient site personnel to study protocol/procedures. Monitor compliance to FDA Regulations.  Manage study site activities through frequent on-site visits.  Orient site personnel to study protocol/procedures.  Perform interim and closeout study visits.   Communicate findings to investigators and study staff at the site.   

 

Some required qualifications include at least a RN, BS or similar degree (CRCC) with at least 2 years experience in monitoring cardiac IDE studies.  The candidate must be very familiar with all FDA regulations governing IDE trials.  Must be flexible and willing to travel up to 90% of the time.  Excellent written and computer skills required.

 

Agency calls will not be accepted.