Covance

  • Start-Up Specialist I

    Job Location(s) AR-Buenos Aires
    Job Number
    2018-20977
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    Covance is seeking a Start-Up Specialist to join our team in Buenos Aires, Argentina.

     

    Come work as a Start Up Specialist I at the top Clinical Research Organization. We offer great benefits with opportunities to grow and learn alongside accomplished professionals. This is a full time, office based position with a competitive salary and benefits.

     

    The Company - COVANCE

     

    As one of the world's largest and most comprehensive drug development services companies, Covance has helped pharmaceutical and biotech companies develop one-third of the all prescription drugs in the marketplace today.

     

    The Position

     

    We are currently seeking a Start-up Specialist to join our Clinical Operations team. The ideal candidate should have familiarity with investigator start up documents, previous interaction with operational project team/investigative sites and working knowledge of ICH, FDA, IRBIEC guidelines.

     

    Responsibilities/Duties:

    Overview: Serve as a liaison between Sponsor, investigative sites and Covance. Negotiate contracts and budgets with investigative sites; and collaborate with internal project team to ensure negotiations occur within timelines.

    • Deliver Start-up component of assigned studies within the country or globally. Including accountability of delivery time, cost and quality for assigned activities.
    • Primary contact with investigative sites during the site start-up activities
    • Responsible for working with investigative sites to collect the required investigators and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor.
    • Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
    • Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization and conduct of global clinical trials
    • Where applicable, provide logistical support of clinical trial supply coordination
    • Develop Project specific plans for Startup component of assigned studies
    • Liaise with Operational Project Teams regarding project issues
    • Collect, review, approve process and track regulatory & investigator documents required for study activation in accordance with SOPs, GCP ICH Guidelines and Investigator Package Plan
    • Review and Approve cre English patient informed consents for compliance to international requirements and protocol as applicable.
    • Review and approve core Country Patient informed consents for required elements
    • Resolve informed consents and contractual language issues for exercising advance judgement when interacting with study sites
    • Negotiate contract and budget with investigative sites
    • Liaise with Sponsor and Covance regulatory regarding document submission requirements
    • Maintain and update documents tracking, site address and contact information in the site Information
    • Assess impact of changes in study personnel and document amendments on regulatory documents (including Informed Consent) and process / review/ approve new documents according to GCP/ICH guidelines
    • Assess impact of study amendments on Informed Consent and other study documents and revise and review / approve accordingly
    • Prepare new investigator submission package s to Local and / or Central IRB/ IEC
    • Attend ongoing training in GCP, project specific requirements and as may generally be required
    • Provide milestone information for incorporation into weekly analysis sheets
    • Monitor performance of Start-Up team with regard to project timelines, etc.

    Education/Qualifications

    University / College Degree ( life science preferred) , or cortication in a related allied health profession from the appropriate accredited institution (e.g nursing certification, medical or laboratory technology) and 2 years work experience in clinical research, including a strong working knowledge  of the ICH guidelines and FDA, IRB/IEC regulations.

    Experience

    • Strong networking abilities and an ability/ willingness to work with internal and external stakeholders across the globe
    • Good organizational and time management skills
    • Excellent communication /writing skills
    • Strong computer skills with an ability to access and leverage technology alternatives
    • Abilities to review / analyze relevant data so as to assist in building evidence-based clinical trials strategies
    • Self-motivated with ability to work under pressure to meet deadlines
    • Work well independently as well as in team environment
    • Detail and process oriented
    • Positive attitude and approach
    • Multi-tasking capacity
    • Ability to work independently

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