Description

Qualifications

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

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