Contracts Specialist II

Job Description:

Job Title: Contracts Specialist II


Job Location: United States - Remote


Job Overview:

The Contracts Specialist II (CS) works in collaboration with project teams and the Contracts Manager to perform key study start-up tasks related to site contracts in their country, or countries, of expertise. These tasks may include country-specific contract template development, site contracts and budget negotiations with participating study sites, review of document translations, and other study start-up activities, as needed for delivery of Clinical Contracts assignments and work obligations. The Contracts Specialist is responsible for the negotiation, execution, and proper filing and tracking of study site contracts within their country or countries of expertise. May coach, mentor, or on-board more junior Specialists


Job Duties and Responsibilities:

• Provides country-level expertise and supports the Project Team and Sponsor to agree on country template contract, including review of translated documents as applicable.
• Builds relationships with sites and investigators within country of expertise
• Responsible for distribution, collection, and review of site contract and budget documents either directly or through coordination with assigned CRAs in specific countries. May be assigned to sites with complex internal processes or requiring empowerment to independent decision making
• Negotiates contracts with sites and works with Contracts Manager and Sponsor until resolution of issues.
• Ensures quality of documents and arranges execution of CTAs as well as archival of documents into relevant Caidya systems.
• Responsible for review and negotiation of site study budget
• Perform timely and accurate data entry of site contract and budget statuses in applicable tracking system(s)
• Works in collaboration with the Contracts Manager to ensure to communicate negotiation statuses to the Project Team and Sponsor
• Reviews contracts for completeness and accuracy and ensures that corrections are made and documented.
• In collaboration with the Contracts Manager, forecasts country/site contracting timelines, ensures they are complied with, and tracks milestone progress in agreed-upon Caidya tracking system in real-time.
• Facilitates the execution of contracts by company signatories.
• Supports in maintaining contract templates and site-specific files and databases.
• Ensure all relevant documents are submitted to the TMF as per requirements.
• May be assigned to coach, mentor or on-board new hires or junior Specialists
• Contributes into functional improvement initiatives

Supervisory Responsibilities:

• No supervisory responsibilities

Job Requirements:

Education

• BA/BS degree in related field or equivalent combination of education and experience

Experience

• 2+ years of experience developing, reviewing and processing clinical study site contracts. Experience working at a CRO is preferred, but not required.
• Advanced understanding of local health authority requirements related to country-specific site contract and budget practices preferred
• Strong skills in Microsoft Office Suite, email, and voicemail

Skills/Competencies

• Good understanding of clinical trial process across Phases II-IV and ICH GCP Ability to interact effectively and appropriately with investigative site personnel
• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks effectively
  
  
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