Clinical Research Contract Specialist (Full Time, Days)

Nicklaushealth; Sunset Corners (FL); On-site; USD 60,000 - 90,000; Full time

Job summary

Nicklaus Children’s Health System seeks a Contract Administrator to facilitate the preparation and execution of agreements with pharmaceutical, biotechnology, medical device and academic partners. You will coordinate HRPP/OSP processes to ensure documents are clear, fair, and legally binding, and support day-to-day contracting activities.

Based in Sunset Corners, Florida, the role requires a Bachelor’s in Business or related field with 2–4 years of contract negotiation; JD or related master

Qualifications

• Bachelor's degree required in business or related field.
• 2–4 years experience in contract negotiation.
• JD or Master’s degree preferred.
• Experience in pediatric clinical research preferred.
• Familiar with federal/state/international research regulations.
• Excellent communication and organizational skills.

Responsibilities

• Ensures clinical research activities comply with applicable regulations.
• Creates, drafts, reviews contractual agreements and grant documents.
• Performs initial and ongoing review of contracts from clients and suppliers.
• Prepares contract approval timelines and leads follow-up to obtain approvals.
• Ensures contracts are accurate, complete, and signed in a timely manner.
• Conducts contract negotiations and client interactions.
• Consults with General Counsel to review terms and develop templates.
• Ensures consistency of terms between consent and agreements.
• Manages contract dissemination and filing through email and tracking system.
• Coordinates among Research Institute clients, suppliers and vendors for timely execution.
• Maintains up-to-date tracking of all contracts and client correspondence.
• Prepares ad hoc reports and uses contract software to improve processes.
• Reviews and processes vendor agreements as requested by leadership.

Skills

Contract negotiation

Legal documentation

Communication skills

Organization

Project coordination

MS Office

Education

Bachelor's Degree in Business Administration or related field

Juris Doctorate or Master’s degree preferred

Tools

Electronic Medical Records (EMR)

Clinical Trial Management System (CTMS)

Contract management software

Microsoft Word/Excel/PowerPoint

Job description

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).

Minimum Job Requirements:

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

Knowledge, Skills and Abilities

• 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
• 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

ESSENTIAL JOB DUTIES:

• 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.

Job: Clerical/Administrative

Department: OFFICE OF SPONSORED PROGRAMS-2100-310950

Job Status: Professional