Home-Based CRA/Protocol Monitor
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland. EMMES is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research. EMMES is seeking a permanent, Home-Based Clinical Research Associate with at least 2 year of outside monitoring experience.
This position will support a variety of trials, covering a wide range of therapeutic areas.
*Must be willing to travel approximately 40-50 percent of the time.
· 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
· Conduct 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
· Degree in health related field preferred
· 2 years plus years of outside monitoring experience required
· Knowledge of GCP, and HSP regulations
· Variety of therapeutic areas a plus but not required
· 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 40-50% of the time, potentially some International sites
· 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.
Please visit our website at www.emmes.com for additional information on our company, studies and history.
EMMES is proud to be an Equal Opportunity Employer. EOE/M/F/D/V