Description

The Clinical Data Manager will be responsible for data management of clinical research studies. You will collect and transcribe research patient data and study related information into research records and maintain study patient files. You will work with study monitors to collect accurate data in a timely manner and assist investigators and study coordinators in clinic settings. You may also be responsible for ensuring protocol procedures are completed accurately, safely, and in a timely manner, under the supervision of the Principal Investigator. Additional responsibilities include regulatory compliance, patient recruitment and enrollment, data collection, research chart documentation, quality assurance, report preparation, protocol information dissemination to health care professionals, patients and their family members. You will ensure investigational product is adequately managed and documented. Work may be assigned by the manager, team leader, investigator or Senior Management, and assignments may be changed on an as-needed basis in order to ensure that studies and patient care needs are handled appropriately and in a timely manner. The ideal candidate would be available occasionally to work flexible hours to meet study or CRU deadlines and priorities. Hourly Salary Range: $32.65 - $52.53

Qualifications

Required: * Bachelor's degree or 1-3 years of previous study coordination or clinical research coordination experience * Strong verbal and written communication skills along with strong interpersonal skills to effectively establish rapport, and build collaborate relationships. * Strong organizational capabilities to organize multiple projects and competing deadlines for efficiency and cost-effectiveness. * Analytical skills sufficient to work and solve address problems and identify solutions with reasoned judgment. * Ability to adapt to changing job demands and priorities; work flexible hours to accommodate research deadlines. * Ability to respond to situations in an appropriate and professional manner. * Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines. * Ability to be flexible in handling work delegated by more than one individual. * Typing and computer skill/ability including word-processing, use of spreadsheets, email, data entry. Ability to navigate numerous software programs and applications. * Ability to handle confidential material information with judgement and discretion. * Working knowledge of the clinical research regulatory framework and institutional requirements. * Mathematical skills Sufficient to prepare clinical research budgets, knowledge of math ability and knowledge of clinical trials research budgeting process to assist with the preparation of clinical trial budgets. * Working knowledge of FDA Code of Federal Regulations (CFR) and ICH Good Clinical Practice (GC) for clinical research. * Be available to work in more than one environment, travel to meetings, off-site visits, conferences, etc.