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Clinical Research Associate

Company: University of Arkansas Medical Center
Location: Little Rock
Posted on: April 17, 2019

Job Description:

Overview The Clinical Research Assistant will be responsible for data collection and management for CCTRA clinical trials. Position must be able to organize complex projects, provide attention to detail, and communicate effectively. Works closely with CRA Team Lead and CRNs to manage the day-to-day operations and objectives in support of the assigned portfolio. Contributes information and ideas related to areas of responsibility as part of a cross functional team. Ensures effective and efficient workflow and adherence to quality standards for staff/program and self. Position maintains a working knowledge of the Code of Federal Regulations and the code of conduct for human research. The employee will work directly with pharmaceutical company sponsors, institutional investigators, and research staff. The University of Arkansas for Medical Sciences (UAMS) has a unique combination of education, research, and clinical programs that encourages and supports teamwork and diversity. We champion being a collaborative health care organization, focused on improving the health, health care, and well-being of Arkansans. UAMS offers amazing benefits and perks: * Health: Medical, Dental and Vision plans available for staff and family * Holiday, Vacation and Sick Leave * Education discount for staff and dependents (undergraduate only) * Retirement: Up to 10% matched contribution from UAMS * Basic Life Insurance up to $50,000 * Career Training and Educational Opportunities * Merchant Discounts * Concierge prescription delivery on the main campus when using UAMS pharmacy Salary: offered commensurate with experience. Responsibilities Leadership: * Interprets institutional policies related to clinical trial data collection, management, and reporting to ensure departmental adherence. * Represents the department and investigators at local, regional and national meetings; facilitate effective communication among staff, PIs and other research/clinical professionals, senior leaders of UAMS, and study sponsors. * Serve as the general administrator and liaison for the PI, research subjects, human testing compliance, privacy/HIPAA compliance, other research and clinical professionals, and the granting or funding entity relative to the research protocol. * Ensure strict adherence to all regulatory requirements such as the reporting of serious adverse events in the time-line required by the study sponsor and the Institutional Review Board. * Prepares high-quality written documents; analyzes data and formulates conclusions. * Participate in the development and maintenance of electronic infrastructure and clinical trial management suite. * Advises the PI on administrative requirements necessary as required per protocol. Monitors protocol status and advises PI on requirements and deadlines. Data Collection: * Manages the collection and transmission of samples, scheduling of clinical visits and tests, and the collection, processing, and reporting of data. * Assists departmental faculty/PI in the development, preparation, and submission of research protocols and related documentation. * Confers with PI and support staff to secure necessary documents for proposals. * Assists in the screening, recruitment, selection, consenting, and enrollment of subjects. * Assists with the development, implementation, maintenance, and evaluation of quality assurance plan for conduct of clinical trials, while working closely with sponsor representatives to address and respond to monitoring and auditing reports. May perform other duties as assigned. Qualifications Minimum Qualifications: Level I: Bachelor's degree plus 3 years of general research experience OR High School diploma/GED plus 7 years of clinical research experience. Level II: Bachelor's degree plus 3 years of general research experience with demonstrated experience/proficiency in one or more of the following functional areas as relevant to oncology clinical trials: study planning/development, study coordination/management and data collection OR High School diploma/GED plus 7 years of clinical research experience. Level III: Bachelor's degree plus 5 years of clinical research experience with demonstrated experience/proficiency in all of the above key functional areas (see Level II) OR High School diploma/GED plus 9 years of clinical research experience. Certification: Level I: Obtain Certified Research Specialist (CRS) certification within 2 years of hire Level II: Obtain CRS certification within 2 years of hire Level III: Certified Clinical Research Professionals (CCPR), Certified Clinical Research Associate (CCRA) or equivalent professional certification. This position is subject to a pre-employment criminal background check. A criminal conviction or arrest pending adjudication alone shall not disqualify an applicant. Any criminal history will be evaluated in relationship to job responsibilities and business necessity. The information obtained in these reports will be used in a confidential, non-discriminatory manner consistent with state and federal law. UAMS is an Affirmative Action and Equal Opportunity Employer of individuals with disabilities and protected veterans and is committed to excellence. Physical RequirementsStand: OccasionallySit: FrequentlyWalk: OccasionallyBend, crawl, crouch, kneel, stoop, or reach overhead: OccasionallyLift, push, pull, carry weight: 10 lbs or lessUse hands to touch, handle, or feel: OccasionallyTalk: FrequentlyHear: FrequentlyTaste or smell: OccasionallyRead, concentrate, think analytically: ContinuouslyPhysical Environment: Inside Classroom Setting, Inside Laboratory Environment, Inside Medical Facility Environment, Inside Office EnvironmentNoise Level: ModerateVisual Requirements: Far visual acuity, Near visual acuityHazards: BiologicalSDL2017

Keywords: University of Arkansas Medical Center, Little Rock , Clinical Research Associate, Healthcare , Little Rock, Arkansas

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