In-House CRA in Lawrence, Kansas For Sale

ESSENTIAL DUTIES AND RESPONSIBILITIES: Tasks related to implementation of clinical trials: -Assists in establishing study time lines, and ensures activities are conducted in order to maintain time lines. -Anticipates issues that could impact study progress and communicates issue to appropriate people then takes action to avoid or solve them. -Reviews, gives input, and drafts assigned sections of key study documents such as protocols, informed consents, specimen management manuals, vaccine management manuals, periodic update reports, and final study reports. -Initiates, coordinates, and takes responsibility for the development of supporting documents related to study conduct, such as the review of clinical site source documentation templates, diary cards, tracking tools, monitoring and study guidelines, training materials; reviews/supervises the review of successive drafts for approval. -Ensures receipt and review of required regulatory approval documents and subsequent updates to maintain current regulatory file. Assists as required with preparation and review of documents to be submitted to regulatory authorities. -Assists in formation of proper and timely responses to regulatory authorities*** queries; proposes specific actions and ensures their implementation, including protocol amendments and related study procedures. -Organizes and conducts CRO/vendor/investigator/site staff training, and investigator meetings as needed. -Prepares for site visits as needed, as the actual site monitor or as co-monitor in collaboration with CRO/vendor, including site qualification, study initiation, interim monitoring, and close-out visits in accordance with SOPs. -Works with data management staff to collect clinical data according to data review requirements and study time lines, including development and resolution of queries. -Participates in review of data listings, ensures that data are accurate, complete, consistent. QUALIFICATIONS AND REQUIREMENTS: - 3+ years in clinical trials experience in the biotechnology or pharmaceutical industry -Established project planning and implementation skills -Demonstrated problem solving skills -Demonstrated success working with cross-disciplinary teams -Knowledge of GCP, FDA, CFR***s and ICH guidelines -Ability to work in a multicultural environment Required Skills for In-House CRA Job: CRA BACHELOR'S DEGREE CRC CLINICAL RESEARCH About Aerotek Scientific: Join Aerotek Scientific®LLC, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.