The Emmes Company, LLC ("Emmes") is searching for a CRA Manager
to be located in any of our offices or home-based
. Emmes provides flexibility for the office location or work remote preference dependent upon position.
Emmes, established in 1977, is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.
Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We provide statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Primary Purpose
The CRA Manager in collaboration with project team leaders is responsible for planning, monitoring and coordinating clinical research studies at external study sites. As part of these activities, the CRA Manager will oversee the CRAs for which they are assigned. The CRA Manager ensures monitoring metrics are adhered to and all monitoring deliverables are provided with high quality and consistent with SOPs and project Plans. This position may be home or office-based in any Emmes location. Travel is not expected to be more than 25%. Responsibilities
- Coordinates all monitoring aspects in the execution and support of clinical trial activities
- Supervises and ensures CRA team members are compliant with SOPs, sponsor and regulatory agency expectations for site monitoring activities
- Participates on internal, site and sponsor teleconferences and meetings to address monitoring activities outlined in statements of work
- Critically reviews study protocols, study documents, monitoring reports and Sponsor required plans for communication, monitoring and other required plans
- Implements full scope and risk-based monitoring programs
- Develops and implements tracking systems for key monitoring activities and evaluates defined milestones for these activities
- Reviews and approves travel, expense report and timesheets
- Conducts co-monitoring activities (feasibility, qualification or selection, interim, close out visits, for cause and other visits) as required
- Participates as a team leader in project planning, implementation, problem solving, tracking milestones and deliverables
- Liaises with the Sponsor and the study team
- Leads in the development of key monitoring deliverables such as clinical monitoring plans and site visit report templates
- Helps to identify, train, and mentor new CRAs and monitoring staff
- May prepare monitoring budgets and statements of work for existing and new proposals
- Participates in corporate initiatives as requested
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- Minimum of a Bachelor's degree and a background in clinical research, public health, biological sciences, or other related fields
- Minimum of 5 years of monitoring experience in clinical trials
- Proven supervisory skills and excellent verbal and written communication skills
- Ability to independently plan, lead and summarize conference calls or meetings with project staff, clinical staff, vendors and sponsor representatives
- Prior experience in any of the areas of ophthalmology, transplantation, neurology, vaccine and infectious diseases, cancer, maternal/child health and substance abuse preferred
- ACRP CCRA or equivalent certification preferred
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Emmes is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.