Clinical Contract Associate II (on-site)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. 

We currently have a US office based opening for a Clinical Contract Associate II position with  Sylmar, CA or Maple Grove, MN as preferred location.

   

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

WHAT YOU’LL DO

• 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

EDUCATION AND EXPERIENCE

Required

• Associates Degree (± 13 years)
• Minimum 1 year related experience

Preferred

• Bachelor's Degree in Business Administration, a related field, or equivalent. Sponsor Pharma of Biotech experience preferred. Direct knowledge of Sponsor Clinical Contracting preferred.
• 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 certifcate.
• Negotiations/Skills in redlining documents and analytical experience or equivalent. Familiarity with grant and contract requirements, policies, and procedures including, but not limited to:
• Knowledge of contract law and legal terminology
• Understand fundamental legal principles & terminology
• 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).
• A demonstrated knowledge of the practices/procedures of the function, company polices, and programs. 
• 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.
• Be able to demonstrate and use discretion in exercising work assignments and handle sensitive/confidential information in an effective manner. 
• The demon