Senior Contract Associate

Position Summary:
Working under the direction of manager or senior contract associate, provides technical
assistance in developing, 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 routine
negotiations with little supervision.

Key responsibilities:
 Under minimal guidance & supervision, develop & negotiate contracts, contract
amendments and complex budgets with site partners within expected
timelines/metrics
 Proactively collaborate with external/internal partners to address & resolve
contract/budget issues to meet study milestones and deadlines
 Review informed consents to ensure alignment with contract/agreement and
provide guidance to study teams
 Anticipate potential contract/budget compliance issues and timely risk mitigation

Required Education & Experience
 Associates Degree (± 13 years)
 Minimum 1–2-year related experience

Preferred Education & Experience
 Bachelor’s degree in business administration, a related field, or equivalent.
Sponsor Pharma of Biotech experience preferred. Direct knowledge of Sponsor
Clinical Contracting preferred.
 3-5 years related work experience in Clinical contract/budget or an equivalent
combination of education & experience

 Associate/ Bachelor's Degree in Business Administration, a related field, or
equivalent and/or Paralegal certificate.
 Negotiations/Skills in redlining documents and analytical experience or
equivalent. Familiarity with grant and contract requirements, policies, and
procedures including, but not limited to:
o Knowledge of contract law and legal terminology
o Understand fundamental legal principles & terminology
o Clinical and AdvaMed Code of Ethics on Interactions with Health Care
Professionals
o Knowledge and understanding of GCP, ICH, GLP and other federal, state,
industry rules and regulations governing technical aspects of clinical
grants and contracts
o Ensure all required data from studies and sites to comply with regulatory
and government requirements (Sunshine Act, FWA, Human Subject
Protection training, Clinical Insurance).
o A demonstrated knowledge of the practices/procedures of the function,
company polices, and programs. 
o 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.
o Consistently demonstrates the ability to understand and take effective
approaches to varying levels of communication that would be most
efficient and productive.
o Be able to demonstrate and use discretion in exercising work assignments
and handle sensitive/confidential information in an effective manner. 
o The demonstrated ability to understand and comply with applicable
government regulations and company operating procedures, processes,
policies, and tasks. 
o Demonstrated personal computer skills including working familiarity with
relevant word processing, database, and spreadsheet applications (i.e.,
Microsoft Word, Excel and Access).