Clinical Contracts Associate

Clinical Contracts Associate

6-month +

Onsite in Plano, TX

Responsibilities

• Creating and negotiating Amendments
• Preparing study-site specific budget drafts
• Sending initial contract/budget email to invited sites within specified timelines
• Periodic follow up with sites
• Submitting finalized contracts for signatures
• Scanning of fully executed contracts and revised Investigator agreements
• Uploading of documents to electronic trial master file system and maintaining status notes
• Attending calls and providing regular status updates as required
• Filing of hard copy contracts
• Preparing NTA agreement templates and sending out to sites
• Licensing requests
• Supporting Contracts Manager & Associates as required on assigned tasks

Qualifications

• Minimum of 1-3 years related work experience in clinical research
• Associate’s or Bachelor's Degree in Business Administration, a related field, or equivalent.

Required Skills

• Negotiations/Skills in redlining documents and analytical experience or equivalent.
• Familiarity with grant and contract requirements, policies, and procedures including, but not limited to:
• Clinical and AdvaMed Code of Ethics on Interactions with Health Care Professionals.
• Knowledge and understanding of GCP, ICH, GLP and other federal, state, industry rules and regulations governing technical aspects of clinical grants and contracts
• Ensure all required data from studies and sites to comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance).