Meridian Bioscience

  • Clinical Research Associate - Billerica

    Job Locations US-MA-North Billerica
    Company
    Magellan Diagnostics Inc.
    Department
    Quality & Regulatory Affairs
    # of Openings
    1
  • Job Summary

    The Clinical Research Associate assists in the administrative of clinical research projects including development of key study documents, over-site of the clinical trial, and ensuring the quality and integrity of the data according to GCP, ICH and SOPs.

    Key Duties

    KEY DUTIES:

    • Monitor case report forms and electronic data for quality, completeness, and accuracy
    • Interact with data management and study sites with generation and reconciliation of queries in order to meet business timelines
    • Assist with the creation and collection of required study documents both internally and with the investigational study sites
    • Provide answers to common protocol study related questions under the supervision of the Clinical Director or Associate Trial Manager
    • Assist in the identification and qualification of study sites
    • Monitor study sites (site initiation visit, interim monitoring visits and close-out visits) as needed
    • Assist in execution of laboratory studies and provide support for clinical trials for new products as needed.
    • Keep current on applicable scientific literature.
    • Interact with staff from all departments.
    • Participates in and adhere to the Quality Program as defined by the QSR Adhere to safety SOPs and report potential safety hazards.
    • Support Quality/Regulatory initiatives as a member of the Quality/Regulatory Team.
    • Other duties as assigned.

    Qualifications

    Education/Experience:

    • ​B.A. or B.S. in Biological/Health Sciences
    • Minimum of 1 years experience as a CRA
    • Preferred: minimum of one year research and development experience

     

    Skills, Specialized Knowledge and Abilities:

    • Excellent written and oral communication
    • Basic knowledge in the areas of microbiology, immunology or molecular biology and biochemistry as related to infectious diseases
    • Strong attention to detail
    • Strong problem solving abilities.
    • Able to work successfully under tight timelines
    • Able to manage workload and priorities
    • Ability to read, understand and follow all company SOPs and guidelines and ensures compliance in direct reports.
    • Must possess exceptional communication (written and verbal), interpersonal, problem solving and customer service skills.
    • Ability to maintain regular attendance and punctuality requirements.
    • Willing to travel
    • May be required to work additional hours outside of the normal work shift to ensure business commitments are met (evenings and weekends).
    • Computer proficiency with Microsoft Office projects
    • Be a self-starter, detail oriented, organized and able to prioritize and balance workloads and meet strict critical deadlines along with performing under pressure in a fast- paced environment.
    • Highly motivated, readily adapts to changing priorities, effectively manages own time to ensure tasks, multiple projects are completed on time.

     

    Requirements (Physical, Mental, Environmental Demands):

    • Must be able to concentrate, analyze and solve complex issues throughout the course of the work shift.
    • Ability to walk up and down several flights of stairs throughout the work day in a multi-location facility.
    • Must have the ability to lift up to 20 pounds of supplies or finished product throughout the work shift.
    • Must be able to wear personal protective equipment (latex or nitrile gloves, face shields/safety glasses, etc.).
    • Must be able to adhere to applicable biosafety practices when on the manufacturing floor or in laboratories
    • Ability to stand, stoop, reach, push and pull throughout the course of the work shift
    • Will be required to be fully gowned for performing tasks in a clean room environment
    • Experiments may involve materials that are considered potentially biohazardous.  Must be able to work with human substances such as blood, urine, mucus, stool etc.
    • Must be able to identify and differentiate color on diagnostic devices or components.

    We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

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