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.
Bachelor’s degree in Business Administration, or other relevant field required
2-3 years’ experience in clinical trials contract negotiation
Nicklaus Children's Hospital, formerly Miami Children's Hospital a world leader in pediatric healthcare. With a medical staff of more than 740 physicians and over 3,500 employees, the hospital is renowned for excellence in all aspects of pediatric medical care from birth through adolescence. Nicklaus Children's Hospital offers more than 40 pediatric specialties and subspecialties, and is home to F...lorida’s only free-standing pediatric trauma center.
Nicklaus Children's Hospital also identified a need in the Miami Metro area for Pediatric Outpatient Centers to better serve the community. To enhance our service to South Florida Families we developed outpatient centers that feature select pediatric healthcare services such as urgent care and physical therapy for children up to 21 years old.
Nicklaus Children's Hospital also opened the Dan Marino Outpatient Center which was established to accommodate children with special needs including comprehensive evaluation. This center has grown and now provides neurological as well as developmental services for special needs children not only in South Florida but South America and Europe as well.
Here at Nicklaus Children's Hospital our goal is to provide the best pediatric healthcare in the world. From our humble beginnings to today's world-class facilities and research institute we strive to serve to provide the very best to children worldwide.