Facilitates the preparation and execution of contractual agreements with pharmaceutical, biotechnology, medical device and technology companies, and academic institutions. Coordinates efforts to help ensure that MCRI, our suppliers and our customers have contractual agreements in place that are clear, fair and legally binding. Oversees and coordinates the day to day administrative functions associated with the contracting process within our Human Research Protections Program (HRPP) at MCRI and the Office of Sponsored Programs (OSP). Maintains and keeps track of current and new contracts
ESSENTIAL JOB DUTIES:
Ensures that clinical research and related activities are performed in accordance with all applicable Federal regulations, MCRI, Miami Children's Health System and sponsor policies and procedures.
Drafts and reviews contractual agreements based upon existing standard templates.
Performs initial 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.
Participates in contract negotiations and client interactions.
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 MCRI clients, suppliers and vendors to facilitate timely execution of agreements.
Maintains up-to-date tracking of all contracts and client correspondence to provide periodic internal update.
Prepares ad hoc reports.
Uses standard computer applications as well as legal/contract software to standardize and improve departmental processes and tracking.
Handles vendor agreements and correspondence as requested by MCRI leadership and processes requests through system.
Creates and manages study profiles within the Clinical Trial Management System (CTMS).
Assigns internal financial tracking number to each study and communicates with the Fiscal department in order to activate the number in the hospital financial system
Juris Doctorate or Master's degree in relevant field, preferred
3 years of research experience, 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
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.
Minimum Job Requirements:
Bachelor's degree in Business Administration, or other relevant field required
2-3 years' experience in clinical trials contract negotiation