Clinical Contract Specialist

Naples, FL
United States

Experience Required
Degree Required
Employment Type
Work Schedule

Job Description

Main Objective:

The Contract Specialist will play a key role in advancing the start-up processes of our of supported clinical and nonclinical research agreements.

Essential Duties and Responsibilities:

  1. Drafting and negotiating a wide variety of contracts using standard template agreements including MTAs, Clinical Trial Agreements, Grants, and NDAs.
  2. Reviewing Investigator Initiated Research Requests to draft clinical trial and research study related agreements (template and non-template) with limited supervision
  3. Negotiating a variety of common contractual issues related to standard template agreements and internal standards along with providing interpretations of contractual rights and obligations internally and externally as needed
  4. Preparation of amendments to contracts, and managing the contract amendment process or addendums to existing contracts
  5. Ensuring that contracts are executed and centrally stored in accordance with corporate guidelines
  6. Creating milestone based budgets for approved projects and Clinical studies as needed
  7. Coordinate with internal R&D team members regarding completed MTAs to facilitate product order delivery to sites
  8. Tracking, filing and maintaining databases for appropriate study administration procedures regarding Compliance HCP tracking
  9. Review and update SOPs as needed for all departmental contract templates
  10. Generate/Track Check Requests for Site Payments and Pass Thru Payments related to R&D Clinical study executed contracts
  11. Assist with development and editing of study related materials as needed by working collaboratively with internal departments to accomplish projects.

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

  • High school diploma or equivalent required
  • Bachelor’s degree or certification as a paralegal preferred
  • Experience in contract management, business administration, legal, finance or other fast-paced business environment in a contracting role, preferred
  • Experience in a medical device, pharmaceutical or other healthcare environment is helpful

Knowledge and Skill Requirements/Specialized Courses and/or Training:

  • Must have the ability to perform as a self-starter with high-level initiative, strong work ethic, and good organization skills.
  • Strong analytical, reasoning, and problem-solving skills are required as well as the ability to multi-task. Shift focus between competing demands easily while working under deadlines and attending to urgencies.
  • Proven ability to learn and adapt in an evolving work environment.
  • Excellent oral and written communication
  • Proficiency with MS Word, Excel, PowerPoint, Access and Adobe Acrobat

Machine, Tools, and/or Equipment Skills:

Experience in Microsoft Office is required

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.