• Clinical Research Associate

    Posted Date 4 weeks ago(5/31/2018 12:18 PM)
    Requisition ID
    2018-42963
    Category
    Administrative
    Position Type
    Regular Full-Time
    Department
    COM Research Admin Cancer CCTRA
    Post End Date
    7/1/2018
  • Overview

    The Clinical Research Associate (CRA) will be responsible for the data collection and management for the Cancer Clinical Trials and Regulatory Affairs (CCTRA) office. This position must be able to organize complex projects, provide attention to detail, and communicate effectively. The CRA must work closely with CRA Team Lead and Clinical Research Nurse(s) (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. The CRA ensures effective and efficient workflow and adherence to quality standards for staff/program and self. The CRA 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.



    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: Negotiable

    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, Principal Investigator(s) (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 timeline 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.
    • Provides training for staff and investigators.
    • Develop and implements process improvement and participates in the development of electronic infrastructure, including UAMS’ clinical trial management suite.
    • Participate in on-going professional training.

     

    Additional duties may be assigned to this position.

    Qualifications

    Minimum Qualifications:

    Bachelor's degree OR High School diploma/GED plus 7 years of clinical research experience required.

     

    Experience:

    • Level I: 3 years of general research experience.
    • Level II: 3 years of general research experience with demonstrated experience/proficiency in one or more of the following functional areas as relevant to oncology clinical trails: study planning/development, study coordination/management and data collection.
    • Level III: 5 years clinical research experience with demonstrated experience/proficiency in the functional areas mentioned above but also including study planning/development, study coordination/management and data collection. Certification for Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA) or equivalent professional certification required.

     

    UAMS is an inclusive Affirmative Action and Equal Opportunity Employer of individuals with disabilities and protected veterans and is committed to excellence. 

    Physical Requirements

    Stand: Frequently
    Sit: Frequently
    Walk: Frequently
    Bend, crawl, crouch, kneel, stoop, or reach overhead: Occasionally
    Lift, push, pull, carry weight: 10 lbs or less
    Use hands to touch, handle, or feel: Never
    Talk: Frequently
    Hear: Frequently
    Taste or smell: Occasionally
    Read, concentrate, think analytically: Continuously
    Physical Environment: Inside Classroom Setting
    Noise Level: Quiet
    Visual Requirements: Near visual acuity
    Hazards: None

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