Clinical Research Contract Specialist (Full Time, Days)

Nicklaus Children's Hospital•Miami, FL

2d•Onsite

About The Position

Facilitates preparation and execution of contractual agreements with pharmaceutical, biotechnology, medical device and technology companies, academic institutions, and physician practices. Coordinates efforts to help ensure 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 organization's Human Research Protections Program (HRPP) at the Research Institute and the Office of Sponsored Programs (OSP). 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.

Requirements

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

Nice To Haves

Juris Doctorate or Master’s degree in 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
Experienced with electronic medical record and clinical trial management software applications preferred

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