Clinical Research Contract Specialist (Full Time, Days)

About the Role

Facilitates preparation and execution of contractual agreements with pharmaceutical, biotechnology, medical device and technology companies, academic institutions, and physician practices. Coordinates efforts to ensure the Research Institute, suppliers, and customers have contractual agreements in place that are clear, fair, and legally binding. Oversees and coordinates day-to-day administrative functions associated with the contracting process within the organization's Human Research Protections Program (HRPP) at the Research Institute and the Office of Sponsored Programs (OSP).

Requirements

• Bachelor’s Degree in Business Administration or other relevant field (required)
• 2-4 years of experience in contract negotiation

Qualifications

• Juris Doctorate or Master’s degree in a relevant field preferred
• Prior experience in clinical trials contract negotiation 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
• Experience 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

Responsibilities

• 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 to activate the number in Nicklaus Children’s Health System's financial system.

Department: Office of Sponsored Programs