Clinical Trial Assistant

Job Title: Clinical Trial Assistant

Job type: Permanent

Location: Lexington, MA

Company overview: CSA Medical, Inc. is a small medical device company located in Lexington, MA dedicated to improving the lives of those patients with Chronic Obstructive Pulmonary Disease (COPD) with Chronic Bronchitis (CB).  CSA Medical has developed a breakthrough medical device, RejuvenAir^®, designed to address the underlying cause of COPD, a significant unmet clinical need and the 3rd largest killer in the U.S. A successful feasibility study conducted with 35 patients in the EU has paved the way for an IDE study in the United States.

Job Summary: CSA Medical is looking for a Clinical Trial Assistant to assist with clerical and administrative responsibilities in support of the RejuvenAir pivotal IDE.  This person will act as the administrative core of the clinical department ensuring operations run effectively, efficiently, and in a professional manner.  This position will report to the Director of Clinical Affairs.

  Key Duties:

Administer, maintain and coordinate the logistical aspects of the clinical trials according to GCP and SOPs and per the direction of the Clinical Trial Manager(s).

Ensures timely and accurate study-related communication to internal and external study team (including CRO and site personnel as appropriate): assists in preparation, distribution and tracking (as needed) of clinical trial correspondence, newsletters, etc., and assists with the creation of study-specific manuals, tools, and templates.

Set-up, maintain and perform quality checks of study documentation / Trial Master File(s)

Supports management of study device and accountability

Work side-by-side with CTM and/or CRA assisting in some of their tasks as delegated

Provide support for field based clinical personnel via maintenance and communication of site visit tracking information and metrics

Develop, review and/or facilitate review of various study documents and CRFs

Establish and be the central contact between the contract services, study team and study sites as delegated

Routine meeting management to provide agenda, minutes and action points for meeting as needed

Maintain tools and tracking to report and measure study progress.

Skills/Competencies

Minimum of 2 years of experience in Clinical Operations.

Bachelor's degree in a relevant field is preferred.

Ability to work independently but knows when to involve / collaborate with others

Must have the ability to function in an atmosphere of changing priorities and tight deadlines

Self-motivated and thrives in a team-oriented environment

Solid oral and written communication skills and strong attention to detail

Excellent computer skills including Word, Excel and Power Point. 

Experience with graphic design software for newsletter generation is desirable

Please send all resumes to: hnigro@csamedical.com