STRATEGIC SERVICES ASSOCIATE, DCRI - Strategic Development/Contracts


diversity employer



STRATEGIC SERVICES ASSOCIATE, DCRI - Strategic Development/Contracts
DCRI - Strategic Development/Contracts

Who We Are:
As the world's largest academic clinical research organization and part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. We are dedicated to advancing clinical research by promoting innovation, education, scientifically designed studies, and operationally efficient clinical trial conduct.

OCCUPATIONAL SUMMARY
Under limited 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 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.

PRIMARY DUTIES
1. 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 • amendments • grant and gift letters
2. 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.
3. Negotiate draft subcontracts and agreements (examples noted above) applying a solid understanding of the Duke/DCRI mission, policies, processes, structure and systems, especially those pertaining to clinical research, academic consents 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)
4. Have a working knowledge of the Big Four and the ability to articulate an understanding of these terms.
5. Develop and maintain DCRI Contracts departmental templates for site agreements and other minor subcontractor I vendor I partner agreements.
6. 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.

Other Responsibilities
1. Attend and participate in DCRI Contracts departmental meetings.
2. Maintain accurate contracts records in departmental contracts tracking system.
3. Maintain thorough and open communications related to ongoing projects with DCRI Contracts management, DCRI project teams and administrative personnel.
4. Lead and participate in ad hoc departmental initiatives and special projects as assigned by the AD of Contracts Management.


Requisition Number
401303525

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1655 STRATEGIC SERVICES ASSOCIATE

Job Family Level
70

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Education
Work requires a Bachelor's degree in Business related field.

Experience

Work requires a minimum of three years of related business/administration experience.
Three years of 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, is highly preferred experience
Advanced degree (J.D., M.B.A., Ph.D.) or course work completed toward such degree may substitute for years of experience.

Skills
Analytical, problem solving, and negotiation skills Excellent organizational, planning and prioritization skills Excellent attention to detail Excellent oral and written communication skills Excellent proofreading skills Knowledge of agreements used in support of clinical trials preferred Excellent interpersonal skills Knowledge 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, etc.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each


Auto req ID

92493BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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.

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