• Clinical Site Manager

    Posted Date 1 week ago(1 week ago)
    Requisition ID
    2018-44196
    Category
    Professional
    Position Type
    Regular Full-Time
    Department
    COM Biostatistics DCOC A
    Post End Date
    8/23/2018
  • Overview

    The Data Coordinating and Operations Center (DCOC) for the IDeA States Pediatric Clinical Trials Network (ISPCTN) is a network which will provide rural and underserved children with representation in clinical studies exploring environmental influences on early development and child health. The Clinical Site Manager will be responsible for managing the clinical activities related to the DCOC, which will cover 17 sites.  This individual will provide consultation and instruction to members of the DCOC community. 


     


    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


    • Coordinate and oversee all clinical site management activities including management of the protocol conduct, data collection and review, and coordination of all related communication.

    • Refer to Standard Operating Procedures (SOPs) for guidance on everyday study tasks and contribute to ongoing SOP development and review. 

    • Ensure site management activities are in compliance with study timelines, ICH GCP guidelines, internal SOPs and meet all regulatory requirements.

    • Flexible to meet changes in work environment and study milestones with efficiency and assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.

    • Assist with preparation of sections of study materials and/or training. 

    • Interface with, and ensure training of investigators, site staff, and other assigned staff. 

    • Responsible for coordinating field activities with clinical site needs to ensure enrollment and study execution. 

    • Participate in training to enhance knowledge base.

    • Oversee activities performed by Contract Research Organizations (e.g. CROs, core labs) and able to work in a fast paced and dynamic environment and able to work effectively, independently and on cross-functional teams.

    • Prepare reports, presentations, business correspondence and procedure manuals as required.

    • May perform other duties as assigned.

    Qualifications

    Bachelor’s degree in Business, Management or related field plus 3 years' experience in a clinical setting required.


     


    Knowledge, Skills & Abilities:



    • Must have strong verbal and written communication skills, technical and problem solving skills.

    • Must be able to read, analyze and interpret general business documents, technical procedures, and SOPs

    • Must have knowledge of ICH and GCP Guidelines.

    • Excellent computer skills are critical to function within an environment that relies heavily on technology for information and communication.

    • Must be accurate and pay attention to detail with demonstrated ability to work independently.

    • Must have a valid driver’s license


    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: 11 - 25 lbs
    Use hands to touch, handle, or feel: Never
    Talk: Frequently
    Hear: Frequently
    Taste or smell: Never
    Read, concentrate, think analytically: Frequently
    Physical Environment: Inside Office Environment
    Noise Level: Moderate
    Visual Requirements: Far visual acuity, Near visual acuity
    Hazards: None

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