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 CRA Manager to support studies in various therapeutic areas.
*Travel is not expected to be more than 20%
Primary ResponsibilitiesCoordinates 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 Develops and implements tracking systems for key monitoring activities and evaluates defined milestones for these activities Conducts co-monitoring activities (qualification, selection, interim and close out 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 Assists in the development of key monitoring deliverables such as clinical monitoring plans and report templates Helps to identify, train, 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 4 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
May be remote or office-based in any Emmes location
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Emmes is proud to be an Equal Opportunity Employer. EOE/M/F/D/V