EMMES is seeking a permanent, Clinical Research Associate with at least 1 year of outside monitoring experience.  This position will support a large Pediatric NIH funded clinical trial, covering a wide range of therapeutic areas.   Must be willing to travel at least 65-75% of the time and when not traveling this position will be based in-house at the Rockville, MD office. 

Primary Responsibilities Include:

·          Responsible for writing and distributing time sensitive site visit reports, tracking resolutions of outstanding issues, and ensuring compliance with regulatory requirements, ICH guidelines, Standard Operating Procedures (SOPs), the study protocol and overall research objectives.

·          Participates in protocol review calls with participating sites and prepares resulting summaries.

·          Reviews regulatory documents. Review includes assessment of completeness and compliance with regulatory requirements.

·          Conducts training sessions if necessary for new site personnel on GCP and study protocol requirements.

·           Attends and participates in project and functional area meetings and continuing education.

·          Communicates and coordinates effectively with internal and external clients and colleagues.

Requirements:

·          Degree in health related field preferred.

·          1-2 years of outside monitoring experience required.

·          Knowledge of GCP, and HSP regulations.

·          CCRA preferred demonstrated experience as a protocol monitor or site study coordinator experience desired.

·          Ability to travel to a variety of sites, covering all regions of N. America, approximately 65-75% of the time.

·          Detail oriented, good oral and written communication skills required.

EMMES has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.

*For immediate consideration please submit your resume and apply directly through the company website at www.emmes.com.