Home-Based Clinical Research Associate/Protocol Monitor

Location
Frederick, MD
Posted
Jul 26, 2017
Closes
Aug 03, 2017
Function
Analyst, Research
Industry
Research
Hours
Full Time
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO). 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 Clinical Research Associate with at least 2 year of outside monitoring experience.

*Must be willing to travel approximately 70 percent of the time.

Primary Responsibilities

    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
Requirements

    Degree in health related field preferred 2 years plus years of outside monitoring experience required Oncology and/or transplant experience is a plus 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 70% 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.

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Emmes is proud to be an Equal Opportunity Employer. EOE/M/F/D/V