Job Title: Clinical Contract Associate
Location: Maple Grove, MN or Los Angeles, CA
Client: Large Life Sciences Company
Start Date: July 7th 2025
Duration: contract through end of year, with likelihood of extension
Position Summary:
Working under the direction of the Contracts Manager, applies general knowledge of business developed through education or past experience. No supervisory responsibilities; accountable for personal contribution to team. Uses existing procedures to solve standard problems; analyzes information and standard practices to make judgments. Works within standardized procedures and practices to achieve objectives and meet deadlines; Supports team with entry level tasks. Exchanges straightforward information, asks questions and checks for understanding.
WHAT YOU’LL DO:
• 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
EDUCATION AND EXPERIENCE YOU’LL BRING
Required:
· Minimum of 2-3 years related work experience in Contracting
· Associate 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).
· Requires a demonstrated knowledge of the practices/procedures of the function, company polices, and programs.
· Requires demonstrated written and verbal communication, interpersonal, presentation, technical, analytical, statistical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees.
· Consistently demonstrates the ability to understand and take effective approaches to varying levels of communication that would be most efficient and productive.
· Must be able to demonstrate and use discretion in exercising work assignments and handle sensitive/confidential information in an effective manner.
· Must have the demonstrated ability to understand and comply with applicable government regulations and Company operating procedures, processes, policies, and tasks.
· Must have demonstrated personal computer skills including a working familiarity with relevant word processing, database, and
spreadsheet applications (i.e., Microsoft Word, Excel and Access). Some evaluation, originality, and/or ingenuity required.
Preferred:
Bachelor's Degree in Business Administration, a related field, or equivalent.
Sponsor Pharma or Biotech experience preferred. Direct knowledge of Sponsor Clinical
Contracting and clinical research preferred.
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