What are the responsibilities and job description for the Clinical Contracts Associate position at GForce Life Sciences?
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).