In-House CRA Manager

The EMMES Corporation, established in 1977, is a woman-owned, private 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 are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. We offer comprehensive clinical research expertise from trial conception to marketing submission. Emmes is seeking an In-House CRA Manager.

Primary Purpose

The In-House CRA Manager in collaboration with project teams is responsible for the leadership in planning, monitoring and coordinating clinical research studies at external study sites. As part of these activities, the In-House CRA Manager will support and provide clinical operations oversight of the In-House CRAs responsible for site activation processes including collection, review and approval of site essential documents, follow up on site action items related to monitoring visits, and general site management support for which they are assigned. This position may be office-based in the Emmes Rockville location. Travel is not expected to be more than 10%.

Responsibilities

• Coordinates all monitoring aspects in the execution and support of site activation for clinical trial activities, in collaboration with the Regulatory Operations Group.
• Supervises and ensures In-House CRA team members are compliant with SOPs, sponsor, and regulatory agency expectations for In-House site activation and management activities
• Participates on internal, site and sponsor teleconferences and meetings to address site activation activities outlined in statements of work
• Assists in the development and critical review of study protocols, study documents, study status reports and Sponsor required plans for communication, site activation, site management, monitoring and other required plans
• Supports full scope and risk-based monitoring programs
• Develops and implements tracking systems for key site activation activities and evaluates defined milestones for these activities
• Conducts internal quality assurance activities related to good documentation practices as required for essential document collection and review
• Participates as a team leader in project planning, implementation, problem solving, tracking milestones and deliverables
• Liaises with the Sponsor and the study team
• Assists in the development of key In-House site activation deliverables such as the TMF filing plan, site activation metrics, and report templates
• Helps to identify, train, supervise, and mentor new CRAs and monitoring staff
• Participates in corporate initiatives as requested

Minimum of a Bachelor’s degree and a background in clinical research, public health, biological sciences, or other related fields Minimum of 5 years’ clinical operations experience. 2 years’ experience specifically in study start-up, site activation, and essential document development/review and/or a combination of monitoring experience in FDA-regulated 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 Ability to train and mentor new staff in the study startup and essential document review process. 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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The EMMES Corporation 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, citizenship status, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.