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Clinical Agreements Negotiation Specialist
2 months ago
Position Overview:
The Clinical Contract Management Associate will play a pivotal role in the evaluation and negotiation of numerous clinical study agreements and associated documents for Eastern Virginia Medical School. This role necessitates collaboration with international partners, faculty, staff, and legal counsel throughout the contracting process. The ideal candidate will possess meticulous attention to detail, exceptional organizational and administrative skills, and the ability to manage multiple projects within a fast-paced environment.
Telework Opportunity: The incumbent may qualify for up to three days of telecommuting in accordance with institutional policy.
Key Responsibilities:
- Maintain a comprehensive spreadsheet of clinical contracts involving industry sponsors, federal and state entities, and private foundations, ensuring compliance with relevant laws and regulations while adhering to institutional policies and procedures.
- Provide independent recommendations regarding alternative contract language and assist in contract amendments and budget documentation as required.
- Deliver administrative support and facilitate communication between Grants Accounting and Sponsored Programs.
- Foster effective working relationships with physicians, department leaders, clinical operations, and other stakeholders involved in the contracting process.
- Address contract-related issues and liaise with Legal, Risk Management, and clinical teams to resolve them efficiently.
- Communicate institutional policies and procedures to research support staff and Principal Investigators.
- Assist in the creation, issuance, and routing of subcontracts, modifications, confidentiality agreements, and clinical trial agreements as necessary.
- Act as a backup for Sponsored Programs staff as needed.
- Perform additional duties as assigned.
Qualifications:
A Bachelor’s degree is required, along with a minimum of two years of relevant experience. Experience in a sponsored research or industry setting is preferred. Additional education may be considered in lieu of experience, and vice versa. Candidates must demonstrate the ability to comprehend contract terms, redline agreements, and make informed decisions with a practical approach to contract negotiation. Previous project management experience is advantageous.
Essential Competencies:
- Ability to analyze and interpret technical, medical, and legal documents related to Clinical Trial Agreements.
- Skills in negotiation, planning, strategizing, mentoring, monitoring, and problem-solving.
- Strong written and verbal communication skills, including negotiation proficiency and the ability to present information clearly.
- Sound judgment to protect the institution's interests while ensuring compliance with legal and regulatory requirements.
- Proficient in computer applications, particularly MS Office Suite (Excel, Word, Outlook).