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CLINICAL SERVICES GROUP

MDCI has a number of open positions in our Clinical Services Group, which supports clients through all phases of clinical development and testing, for both new and currently marketed medical devices. At any one time we are involved in the design, management, and monitoring of an average of 20 to 30 medical devices studies, representing varied technologies and therapeutic areas.

SENIOR CLINICAL RESEARCH ASSOCIATE

The Senior Clinical Research Associate is responsible for assisting in the review of all aspects of clinical field trials conducted to determine performance of medical devices in a controlled medical environment, with the following principle responsibilities:

• Conduct on-site pre-investigational site visits, monitor medical device clinical trials, manage study progress, and other required management reports as specified by the clinical trials manager; conduct study closeout visits and pre-FDA inspection site visits
• Collaborate with clinical trials staff in protocol development case report form design, study handbook development, and FDA clinical reports
• Assist with training and supervision of other CRA staff and act as lead CRA as required.
• Travel 50% to 60% of the time.

Qualified candidates will have a minimum B.S. or advanced degree in health science or nursing, with at least 5 years of monitoring experience as a CRA, and a minimum of one year experience in the area of cardiac medical devices. Knowledge of appropriate FDA regulations and guidelines and GCPs, excellent verbal and written skills, and superior communication skills for site/sponsor contact are required. Qualified candidates will have previous experience training and/or mentoring CRAs and acting as a lead CRA. Must have a thorough knowledge of MS Word, Excel, PowerPoint, and Outlook. Certification as CRA by ACRP, SoCRA, or other professional organization preferred.

CLINICAL RESEARCH ASSOCIATES

(East Coast, Midwest, South, Texas)

Responsibilities include monitoring and auditing of clinical data for medical device studies, including requiring frequent interaction with physicians and/or health care professionals. 60% to 70% travel required.

Minimum qualifications include B.S. in science field, nursing, or related education. Qualified candidates will have a minimum of 2 years of current monitoring experience, along with excellent verbal and written communication skills and experience with MS Word, Excel, and Outlook.

SAS PROGRAMMER (TEMPORARY, FULL TIME POSITION)

Primary duties and responsibilities:

• Develops SAS programs used to generate tables, listings, graphs, and figures.
• Reviews SAS programs developed by Biostatisticians and outside consultants.
• Reviews data for problems and issues which affect statistical reports.
• Develops programs for use in data entry verification.

Experience/skill requirements:

• Three years of SAS programming which involves the extensive use of data sets programming.
• Experience producing SAS output or output generated in another software package from SAS datasets suitable for inclusion in FDA submissions.
• Familiarity with medical terminology.
• Familiarity with descriptive statistics.

Educational requirements:

• B.A. or B.S. with concentration in any or all of: mathematics, computer science, or statistics.