School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
supervision, guidance, and mentorship of the Assistant Director (AD) of Contracts Management and/or Senior Attorney the Contracts Associate II will develop and negotiate agreements with subcontractors, academic institutions, clinical sites and other vendors/partners utilizing a working
knowledge and understanding of the Duke Clinical Research Institute (DCRI)/Duke University (Duke) mission, policies, processes, structure and systems, especially those pertaining to clinical research, academic concerns and non-profit tax status. A Contract Associate II will exercise good, sound legal and business judgment. Additional responsibilities will include using, updating, and maintaining software, systems, and procedures that support the development, processing, and tracking of contracts, subcontracts, and/or site agreements for the DCRI. A Contracts Associate II will also serve as a therapeutic area (T/A) lead for assigned T/As; maintains templates; provide input on office systems (filing, tracking, etc.); and demonstrate a working
knowledge of DCRI/Duke mission policies, processes, structure, and systems.
- Negotiate/draft subcontracts and collateral agreements including, but not limited to
- master subcontractor agreements
- faculty research agreements
- confidentiality agreements
- data use agreements and business associate agreements
- site agreements
- letters on intent
- committee member agreements
- lab services agreements
- outside services agreements
- grant and gift letters
Create draft subcontracts and agreements (examples noted above) with reasonable skill and exceptional attention to detail, making use of available templates as well as the ability to draft a contract scratch.
Negotiate draft subcontracts and agreements (examples noted above) applying an working understanding of the Duke/DCRI mission, policies, processes, structure and systems, especially those pertaining to clinical research, academic concerns and non-profit tax status. This would also include a knowledge of our required 1) publications terms, 2) confidentially, 3) intellectually property, 4) and access to data (i.e., the Big Four)
Have a working knowledge of the Big Four and the ability to articulate an understanding of these terms.
Develop and maintain DCRI Contracts departmental templates for site agreements and other minor subcontractor / vendor / partner agreements.
Provide support, legal oversight, and document review for SSU as required. This includes drafting of study template site agreements; review of site negotiations/changes; attendance/leadership of periodic project review teleconferences; and training of SSU associates.
- Attend and participate in DCRI Contracts departmental meetings.
Maintain accurate contracts records in departmental contracts tracking system.
Maintain thorough and open communications related to ongoing projects with DCRI Contracts management, DCRI project teams and administrative personnel.
Lead and participate in ad hoc departmental initiatives and special projects as assigned by the AD of Contracts Management.
HIRING SPECIFICATIONS Education
Bachelor’s Degree in business, science or other related discipline or equivalent relevant work experience. Experience
Three years experience in contracts management and/or research and development arena (pharmaceutical company, CRO, ARO, etc.) with particular emphasis in contract administration and/or related contract generation and document management systems, or other relevant work experience. Advanced degree (J.D., M.B.A., Ph.D.) preferred. Skills
Analytical, problem solving, and negotiation skillsExcellent organizational, planning and prioritization skillsExcellent attention to detailExcellent oral and written communication skillsExcellent proofreading skillsKnowledge of agreements used in support of clinical trials preferredExcellent interpersonal skillsKnowledge of clinical trials process/standards/regulations preferred Familiarity with all internal processes and approvals that impact contracting procedures
Willingness to attend training courses and contracting management courses, software courses, industry shows,
Work requires a Bachelor's degree
Work requires a minimum of three years of related business/administration experience.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.