Summary

Our client, a Fortune 500 Medical Device Company, has engaged GForce Life Sciences to provide an entry level Clinical Contracts Associate. Working under the direction of the manager or senior contract associate, the Clinical Contracts Associate provides technical assistance in negotiating, reviewing, and processing clinical study and research contracts and budgets. Understands key business drivers and corporate clinical priorities; uses this understanding to accomplish own work. No supervisory responsibilities. Solves problems in straightforward situations; analyzes possible solutions using technical experience, judgment and precedents. Impacts quality of own work and the work of others on the team; works within guidelines and policies. Explains complex information to others in straightforward situations. Capable of negotiations with some supervision.

Job Duties

• 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

Mandatory Requirements

• 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.
• 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).
• Sponsor Pharma or Biotech experience preferred.
• Direct knowledge of Sponsor Clinical contracting preferred

Term & Start

• Contract through the EOY with potential to extend
• Locations for onsite: Maple Grove, MN, Santa Clara, CA, Plano, TX or Burlington, MA
• 4 days onsite with flexibility
• Benefits available (Medical, Dental, Vision, 401k)