Description

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  Bachelor's Degree Business Administration, or other relevant field required (Required)
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  2-4 years experience in contract negotiation

Qualifications

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  Prior experience in clinical trials contract negotiation/execution highly preferred
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  3 years of research experience preferred
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  Experience in pediatric clinical research in a hospital setting preferred
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  Clinical research certification (such as ACRP, MAGI or SOCRA) preferred
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  Experienced with electronic medical record and clinical trial management software applications preferred
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  Working knowledge of Federal, State and/or International research regulations
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  Excellent communication and relationship building skills
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  Detail-oriented with excellent organizational skills
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  Self-confident, flexible, and adaptable to change
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  Demonstrated ability to manage multiple complex projects simultaneously
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  Proficient with basic software applications including Word, Excel, and PowerPoint

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  Ensures clinical research and related activities are performed in accordance with all applicable Federal regulations, Research Institute, NCHS and sponsor policies and procedures.
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  Creates, drafts, and reviews contractual agreements and grant award documents.
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  Performs initial and ongoing review and provides comments on contractual agreements received from clients and suppliers including AAHRPP language.
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  Prepares contract approval timelines with all parties involved and leads follow-up efforts to obtain contract approval.
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  Ensures contracts are accurate, complete, signed by the appropriate parties and submitted in a timely manner.
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  Conducts contract negotiations and participates in client interactions.
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  Engages with Nicklaus Children’s Health System’s General Counsel as needed to review contract terms and assist with developing research-appropriate contract templates.
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  Ensures consistency of terms between informed consent forms and agreements.
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  Manages dissemination and filing of contractual agreements through email and contract tracking database.
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  Coordinates efforts, as directed, among Research Institute clients (internal and external), suppliers and vendors to facilitate timely execution of agreements
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  Maintains up-to-date tracking of all contracts and client correspondence to provide periodic internal updates.
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  Prepares ad hoc reports.
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  Uses standard computer applications as well as legal/contract software to standardize and improve departmental processes and tracking.
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  Reviews, negotiates, and processes vendor agreements and correspondence as requested by Research Institute and OSP leadership.
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  Creates and manages study profiles within the Clinical Trial Management System (CTMS).
  


• Assigns internal financial tracking number to each study and communicates with Finance in order to activate the number in Nicklaus Children's Health System's financial system.

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