General Information

Location: Cary, NC

Organization: Clintrax Global

Job Type: Full Time

Description and Requirements

The Contracts Analyst, at our Cary office location, manages the contract negotiation process with clinical trial sponsors and sites both domestically and abroad. 

EDUCATION REQUIREMENTS:

  • Bachelor’s degree required

QUALIFICATIONS/EXPERIENCE:

  • One year experience in clinical trial setting and/or pharmaceutical industry preferred. 

  • Must have intermediate knowledge of Microsoft Word, Excel, and Outlook.  

  • Attention to detail required in a highly regulated industry.  

  • Ability to work independently, and be a pro-active team player is required.  

  • Must possess excellent verbal and written communication skills.  

  • Ability to proof-read and detect errors in typing, spelling, grammar, syntax and punctuation required.  

  • Medical terminology preferred.

  • Paralegal certification/experience preferred

ESSENTIAL DUTIES/RESPONSIBILITIES:

  • Initiate and manage contract negotiation process with clinical trial sites 

  • Draft, review and assist with negotiation of contractual agreements including but not limited to NDA’s, Clinical Trial Agreements, Contract amendments, Indemnity agreements, Facility use agreements, Master agreements, etc.  

  • Negotiate contract terms, budgets and payment schedule, ensuring that the agreements with investigative sites are aligned with clients’ interests.  

  • Produce error-free documents for final execution. 

  • Ensure that per patient and site budgets comply with study parameters.  

  • Prepare and facilitate budget escalations for client approval and collects necessary support documentation.  

  • Ensure contracts are accurate and reflect all negotiated changes, complete, signed by the appropriate parties and submitted in a timely manner.  

  • Participate in conference calls, conferences, negotiations and meetings with internal departments and external sponsors and CROs as necessary.  

  • Prepare contract execution timelines with all parties involved and lead follow-up efforts to obtain contract approval on a weekly basis.  

  • Master and seek to improve internal contracting process by identifying and executing performance metrics. 

  • Work collaboratively with Project Associates to maintain document status reports and ensures all information is current and accurate for assigned studies.  

  • Build and maintain excellent relationships with colleagues and sites. 

  • Maintain updated information of all study related information to use as reference in daily duties. 

  • Stay abreast of changes in studies and/or updates to client preferences as dictated by Contract Managers in order to ensure documents meet the needs required. 

ABOUT US:

Clintrax Global, Inc., a member of the WIRB-Copernicus Group family, specializes in the negotiation of clinical trial contracts and budgets between biopharmaceutical companies, contract research organizations (CROs), and investigator sites around the world. Clintrax Global has accelerated hundreds of clinical trials since its inception. Supported by technology-driven processes and a network of international attorneys, we have provided services across 65 countries.